Download clobetasol

CLOBETASOL
DRUGDEX® Evaluations
OVERVIEW
1) Class
a) This drug is a member of the following class(es):
Adrenal Glucocorticoid
Corticosteroid, Very Strong
2) Dosing Information
a) Clobetasol Propionate
1) Adult
a) Disorder of skin, Corticosteroid responsive
1) (cream, emollient, foam, gel, lotion, ointment) apply a thin layer TOPICALLY to
affected area twice daily; MAX 50 g/wk or 50 mL/wk; MAX duration, 2 consecutive
weeks
[1]
[2]
[3]
[4]
[5]
[6]
b) Plaque psoriasis (Mild to Moderate)
1) (Olux(R) foam) apply a thin layer TOPICALLY to affected area twice daily; MAX 50
g/wk; MAX duration, 2 consecutive weeks
[39]
c) Plaque psoriasis (Moderate to Severe)
1) (Clobex(R) topical spray) spray on affected areas twice daily and rub in gently and
completely; MAX 50 g (59 mL or 2 fl oz) per week; MAX duration, 4 consecutive weeks
[32]
2) (Clobex(R) lotion) apply to affected areas twice daily and rub in gently and
completely; MAX 50 g (50 mL or 1.75 fl oz) per week; MAX duration, 4 consecutive
weeks
[6]
3) (Temovate(R) E cream, emollient) apply a thin layer TOPICALLY to 5% to 10% of
body surface area twice daily; MAX 50 g/wk; MAX duration, 4 consecutive weeks
[33]
[1]
d) Scalp psoriasis (Moderate to Severe)
1) (shampoo, scalp solution, Olux(R) foam) apply TOPICALLY onto dry scalp once daily
in a thin film to affected areas only; leave in place 15 minutes before lathering and
rinsing; MAX 50 mL/wk
[43]
[44]
[39]
2) Pediatric
a) topical (cream, emollient, gel, foam, ointment, scalp solution), safety and efficacy in
children under 12 years of age have not been established
[1]
[2]
[3]
[4]
[5]
b) topical (spray, lotion, and shampoo), safety and efficacy in children under 18 years of
age have not been established
[32]
[44]
[6]
1) Disorder of skin, Corticosteroid responsive
a) (cream, emollient, foam, gel, ointment) 12 years and older: apply a thin layer
TOPICALLY to affected area twice daily; MAX 50 g/wk or 50 mL/wk; MAX duration, 2
consecutive weeks
[1]
[2]
[3]
[4]
[5]
2) Plaque psoriasis (Mild to Moderate)
a) (Olux(R) foam) 12 years and older: apply a thin layer TOPICALLY to affected area
twice daily; MAX 50 g/wk; MAX duration, 2 consecutive weeks
[39]
3) Plaque psoriasis (Moderate to Severe)
a) (Temovate(R) E cream, emollient; Embeline(R) E emollient) 16 years and older:
apply a thin layer TOPICALLY to 5% to 10% of body surface area twice daily; MAX 50
g/wk; MAX duration, 4 consecutive weeks
[1]
[34]
b) (Clobex(R) topical spray) 18 years and older: spray on affected areas twice daily and
rub in gently and completely; MAX 50 g (59 mL or 2 fl oz) per week; MAX duration, 4
consecutive weeks
[32]
c) (Clobex(R) lotion) 18 years and older: apply to affected areas twice daily and rub in
gently and completely; MAX 50 g (50 mL or 1.75 fl oz) per week; MAX duration, 4
consecutive weeks
[6]
4) Scalp psoriasis (Moderate to Severe)
a) (scalp solution, Olux(R) foam) apply a thin layer TOPICALLY to scalp twice daily;
MAX 50 mL/wk; MAX duration, 2 consecutive weeks
[1]
3) Contraindications
a) Clobetasol Propionate
1) hypersensitivity to clobetasol or any ingredient in the preparation (gel, cream,
ointment)
[49]
2) primary scalp infection (scalp application product)
[3]
4) Serious Adverse Effects
a) Clobetasol Propionate
1) Intracranial hypertension, acute
2) Secondary hypocortisolism
5) Clinical Applications
a) Clobetasol Propionate
1) FDA Approved Indications
a) Disorder of skin, Corticosteroid responsive
b) Plaque psoriasis (Mild to Moderate)
c) Plaque psoriasis (Moderate to Severe)
d) Scalp psoriasis (Moderate to Severe)
DOSING INFORMATION
Drug Properties
A) Information on specific products and dosage forms can be obtained by
referring to the Tradename List (Product Index)
B) Synonyms
Clobetasol
Clobetasol Propionate
Clobetasol Propionate, Micronized
Storage and Stability
A) Clobetasol Propionate
1) Preparation
a) Topical application route
1) Do not use occlusive dressings
[1]
[2]
[45]
[3]
[6]
[48]
[47]
.
2) Avoid contact with face or intertriginous areas
[1]
[2]
[45]
[46]
[3]
[6]
[47]
.
3) Cream, Gel, and Ointment
a) Apply a thin layer and rub in gently and completely
[1]
[45]
[47]
.
4) Foam
a) Dispense onto a cool surface and pick up small amounts with fingertips to
apply to affected area. Application amount should not be greater than a golf-ball
size dollop or 1.5 capfuls. Apply smallest amount to sufficiently cover affected
area (excluding the face, groin, and axillae) and gently massage until foam
disappears
[2]
.
b)
[2]
.
5) Lotion
a) Dispense minimum amount necessary to cover affected area onto fingertips or
directly to affected area and rub in completely
[6]
.
6) Shampoo
a) Apply thin film to dry scalp, massage into affected areas, wait 15 minutes, and
then add water, lather, and rinse hair thoroughly
[48]
.
7) Spray
a) Spray directly onto affected area and rub in gently and completely
[46]
.
B) Clobetasol Propionate
1) Topical application route
a) Cream
1) Clobetasol cream should be stored between 15 and 30 degrees Celsius (59
and 86 degrees Fahrenheit). Do not refrigerate
[4]
.
b) Foam
1) Store clobetasol foam at controlled room temperature, 20 to 25 degrees C (68
to 77 degrees F); excursions permitted between 15 and 30 degrees C (59 and 86
degrees F). Keep away from heat, smoke, or flame. Do not puncture, incinerate or
store at temperatures above 49 degrees C (120 degrees F)
[100]
.
c) Gel/Jelly
1) Clobetasol gel should be stored between 2 and 30 degrees Celsius (36
degrees and 86 degrees Fahrenheit)
[5]
.
d) Ointment
1) Clobetasol ointment should be stored between 15 and 30 degrees Celsius (59
and 86 degrees Fahrenheit). Do not refrigerate
[4]
.
e) Shampoo
1) Store clobetasol shampoo at room temperature, between 20 and 25 degrees C
(68 and 77 degrees F), with excursions permitted between 15 and 30 degrees C
(59 and 86 degrees F). Keep container tightly closed
[99]
.
f) Solution
1) Clobetasol solution for the scalp should be stored between 4 and 25 degrees
Celsius (39 and 77 degrees Fahrenheit). Do not use near open flame
[3]
.
g) Spray
1) Store clobetasol spray at 20 to 25 degrees Celsius (68 to 77 degrees
Fahrenheit). Excursions are permitted between 15 and 30 degrees C (59 and 86
degrees F). Do not freeze, refrigerate or store above 30 degrees C. Spray is
flammable; keep away from heat or flame
[32]
.
Adult Dosage
Normal Dosage
Clobetasol
Disorder of skin
See Drug Consult reference:
TOPICAL CORTICOSTEROIDS - DOSING GUIDELINES
Clobetasol Propionate
Topical application route
Bullous pemphigoid
1) Another small trial reported the successful
treatment of BULLOUS PEMPHIGOID (N=16) with a
combination regimen of oral OXYTETRACYCLINE
(500 milligrams (mg) 4 times daily), oral niacinamide
(400 mg 3 times daily), and topical 0.5% clobetasol
propionate cream. Once lesions began to heal, the
oral doses were tapered over several weeks and
clobetasol was replaced with a moisturizing emollient
(Hornshuh et al, 1997).
Disorder of skin, Corticosteroid responsive
1) For the treatment of inflammatory and pruritic
manifestations of moderate to severe corticosteroidresponsive dermatoses, clobetasol cream, emollient,
foam, gel, lotion, or ointment should be applied in a
thin film to the affected area twice daily. The treated
skin area should not be bandaged or otherwise
covered or wrapped so as to be occlusive. Treatment
should be limited to 2 consecutive weeks, and doses
should not exceed 50 g/wk (or 50 mL/wk for the
solution or 21 capfuls/week for the foam)
[1]
[2]
[3]
[4]
[5]
[6]
.
2) For the treatment of inflammatory and pruritic
manifestations of moderate to severe corticosteroidresponsive scalp dermatoses, clobetasol scalp
application should be applied to affected areas twice
daily, once in the morning and once at night. The
maximum dose is 50 mL/wk for 2 weeks
[3]
.
3) Time to lesion clearance was shorter when
clobetasol lotion was occluded with a hydrocolloid
dressing than when unoccluded clobetasol ointment
was used. Relapse rates were similar for the 2
treatments
[19]
.
Plaque psoriasis (Mild to Moderate)
1) Olux(R) Foam
a) For the treatment of inflammatory and pruritic
manifestations of corticosteroid-responsive
dermatoses, clobetasol foam should be applied in a
thin film to the affected area twice daily. The treated
skin area should not be bandaged or otherwise
covered or wrapped so as to be occlusive. Treatment
should be limited to 2 consecutive weeks and doses
should not exceed 50 g/wk (or 50 mL/wk for the
solution, or 21 capfuls/wk for the foam)
[39]
.
Plaque psoriasis (Moderate to Severe)
1) Clobex(R) Lotion
a) For the treatment of moderate to severe plaque
psoriasis affecting up to 10% body surface area, apply
Clobex(R) lotion to affected areas twice daily and rub
in gently and completely; maximum dose and duration,
50 g (50 mL or 1.75 fluid ounces) per week for up to 4
consecutive weeks. Do not use with occlusive
dressing. Treatment beyond 2 weeks should be limited
to localized lesions of moderate to severe plaque
psoriasis that have not sufficiently improved after the
initial 2 weeks of treatment with clobetasol spray. If no
improvement is seen within 2 weeks, reassess the
diagnosis
[6]
.
2) Clobex(R) Spray
a) For the treatment of moderate to severe plaque
psoriasis affecting up to 20% body surface area, spray
clobetasol on affected areas twice daily and rub in
gently and completely; maximum dose and duration,
50 g (59 mL or 2 fluid ounces) per week for 4
consecutive weeks. Do not use with occlusive
dressing. Treatment beyond 2 weeks should be limited
to localized lesions of moderate to severe plaque
psoriasis that have not sufficiently improved after the
initial 2 weeks of treatment with clobetasol spray. If no
improvement is seen within 2 weeks, reassess the
diagnosis. Additional benefits beyond the initial 4 week
treatment should be weighed against the risk of
hypothalamic-pituitary-adrenal axis suppression
[32]
.
3) Temovate(R) E cream, emollient; Embeline(R) E
emollient
a) The recommended dose of Temovate(R) E cream
or emollient and Embeline(R) E emollient for the
treatment of moderate to severe plaque-type psoriasis
is a thin layer applied topically to 5% to 10% of body
surface area twice daily (maximum 50 g/wk). If using
for more than 2 consecutive weeks, the benefit versus
risk of hypothalamic-pituitary-adrenal axis (HPA)
suppression should be evaluated. If improvement is
not seen within 2 weeks, reassess the diagnosis.
Treatment beyond 4 consecutive weeks is not
recommended. Temovate(R) E cream should not be
used with an occlusive dressing
[1]
[33]
[34]
.
Scalp psoriasis (Moderate to Severe)
1) For the treatment of moderate to severe forms of
scalp psoriasis, clobetasol shampoo, scalp solution,
and Olux(R) foam should be applied to affected areas
on a dry (not wet) scalp once daily in a thin film. It
should be left in place 15 minutes before lathering and
rinsing. The total dosage should not exceed 50 mL/wk.
Treatment should be limited to 4 consecutive weeks
and discontinued when control is achieved. Clobetasol
shampoo is not to be used with occlusive dressings.
Clobetasol shampoo should not be used on face,
groin, or axillae; avoid contact with eyes and lips
[43]
[44]
[39]
.
Vesicular stomatitis
a) Clobetasol propionate mouthwash has been effectively
used in the treatment of oral erosive lesions. The aqueous
solution was composed of 0.05% clobetasol with nystatin
100,000 international units/mL. Ten mL of the solution was
swished for 5 minutes 3 times per day and not swallowed
[26]
.
Pediatric Dosage
Normal Dosage
Clobetasol Propionate
Topical application route
Disorder of skin, Corticosteroid responsive
1) For children 12 years and older with inflammatory
and pruritic manifestations of moderate to severe
corticosteroid-responsive dermatoses, clobetasol
cream, emollient, foam, gel, or ointment should be
applied in a thin film to the affected area twice daily.
The treated skin area should not be bandaged or
otherwise covered or wrapped so as to be occlusive.
Treatment should be limited to 2 consecutive weeks
and doses should not exceed 50 g/wk (or 50 mL/wk for
the solution or 21 capfuls/wk for the foam)
[1]
[2]
[3]
[4]
[5]
.
Plaque psoriasis (Mild to Moderate)
1) Olux(R) Foam
a) For children 12 years and older with inflammatory
and pruritic manifestations of corticosteroid-responsive
dermatoses, clobetasol foam should be applied in a
thin film to the affected area twice daily. The treated
skin area should not be bandaged or otherwise
covered or wrapped so as to be occlusive. Treatment
should be limited to 2 consecutive weeks and doses
should not exceed 50 g/wk (or 50 mL/wk for the
solution or 21 capfuls/wk for the foam)
[39]
.
Plaque psoriasis (Moderate to Severe)
1) Temovate(R) E cream, emollient; Embeline(R) E
emollient
a) The recommended dose of Temovate(R) E cream
and Embeline(R) E emollient in adolescents 16 years
or older for the treatment of moderate to severe
plaque-type psoriasis is a thin layer applied topically to
5% to 10% of body surface area twice daily (maximum
50 g/wk). If using for more than 2 consecutive weeks,
the benefit versus risk of hypothalamic-pituitaryadrenal axis (HPA) suppression should be evaluated.
If improvement is not seen within 2 weeks, reassess
the diagnosis. Treatment beyond 4 consecutive weeks
is not recommended. Temovate(R) E cream and
Embeline(R) E emollient should not be used with an
occlusive dressing
[1]
.
The safety and efficacy of clobetasol (cream, emollient, gel,
ointment, scalp solution) has not been not established in
children under 12 years of age. Pediatric patients may
demonstrate greater susceptibility to topical corticosteroidinduced hypothalamic-pituitary-adrenal axis suppression and
Cushing syndrome than adult patients because of a larger
skin surface area to body weight ratio
[1]
[2]
[3]
[4]
[5]
.
Use of clobetasol shampoo, lotion, and topical spray in
patients under 18 years of age is not recommended because
of potential for hypothalamic-pituitary-adrenal axis
suppression
[44]
[32]
[6]
.
Scalp psoriasis (Moderate to Severe)
a) Scalp solution, Olux(R) Foam
1) The recommended dose of scalp solution and Olux(R)
foam in patients 12 years or older for the treatment of
moderate to severe psoriasis of the scalp is to apply twice
daily, no more than 50 mL/wk and no more than 2
consecutive weeks
[43]
[39]
.
PHARMACOKINETICS
Onset and Duration
A) Onset
1) Initial Response
a) Dermatoses, topical: 10 to 21 days (highly individualized)
[74]
2) Peak Response
a) Dermatoses, topical: 2 months
[75]
B) Duration
1) Multiple Dose
a) Psoriasis, topical: 23.3 days
[74]
to 4 weeks
[76]
ADME
Absorption
A) Bioavailability
1) Excessive topical application may result in systemic absorption which
has been reported to suppress pituitary-adrenal function
[77]
[78]
.
2) The concurrent use of occlusive dressings or application to inflamed
skin may increase percutaneous absorption
[79]
[80]
[81]
[82]
.
3) Following topical administration of 25 g applied to the whole body
(excluding face, genitalia, and the arm from which blood was drawn),
plasma CLOBETASOL levels rose rapidly during the first 3 hours. No
CLOBETASOL could be detected in three patients (two with psoriasis; one
with eczema)
[83]
.
CAUTIONS
Contraindications
A) Clobetasol Propionate
1) hypersensitivity to clobetasol or any ingredient in the preparation (gel, cream,
ointment)
[49]
2) primary scalp infection (scalp application product)
[3]
Precautions
A) Clobetasol Propionate
1) acne vulgaris, rosacea, or perioral dermatitis; use not recommended (cream,
lotion, shampoo)
[50]
[51]
[1]
2) age less than 12 years; pediatric patients more susceptible to systemic
absorption and toxicity (cream, ointment, gel, scalp application)
[1]
[4]
[5]
[3]
3) age less than 18 years; increased risk of systemic toxicity; use not
recommended (lotion, shampoo)
[51]
[50]
4) altered skin barrier; increased risk of systemic absorption (cream, lotion,
shampoo)
[1]
[51]
[50]
5) application to eyes and lips; avoid contact (shampoo)
[51]
6) application to large surface areas; increased risk of systemic absorption
[51]
[50]
[1]
[4]
[5]
7) Cushing syndrome has been reported with systemic absorption of topical
corticosteroids (cream, lotion, shampoo)
[1]
[50]
[51]
8) diabetes mellitus, latent; unmasking has been reported with systemic
absorption of topical corticosteroids (cream, lotion, shampoo)
[1]
[50]
[51]
9) failure to heal; may be evidence of allergic contact dermatitis rather than
exacerbation of condition (cream, gel, ointment, lotion, shampoo)
[1]
[51]
[50]
[4]
[5]
10) hyperglycemia has been reported with systemic absorption of topical
corticosteroids (cream, lotion, shampoo)
[1]
[50]
[51]
11) liver failure; increased risk of systemic absorption (cream, lotion, shampoo)
[1]
[51]
[50]
12) not for application to face, groin, or axillae areas
[51]
[50]
[1]
[4]
[5]
[3]
13) not for ophthalmic, oral, or intravaginal use
[51]
[50]
[4]
[5]
[3]
14) occlusive dressings (eg, shower or bathing cap); increased risk of systemic
absorption
[51]
[1]
[50]
[4]
[5]
[3]
15) prolonged use; increased risk of systemic absorption
[51]
[50]
[1]
[4]
[5]
[3]
16) skin infection, uncontrolled; discontinue use
[51]
[1]
[50]
[4]
[5]
[3]
17) systemic absorption; risk of suppression of the hypothalamic-pituitary-adrenal
(HPA) axis, even at low doses, with the potential of glucocorticosteroid
insufficiency after treatment withdrawal; monitoring recommended; dose
adjustment may be required
[51]
[50]
[1]
[4]
[5]
[3]
18) report suspected adverse reactions to the US Food and Drug Administration
at 1-800-FDA-1088 begin_of_the_skype_highlighting
1-800-FDA1088 FREE end_of_the_skype_highlighting or www.fda.gov/medwatch
[1]
Adverse Reactions
Cardiovascular Effects
Clobetasol Propionate
Edema
a) Edema has commonly been reported in patients treated
with clobetasol propionate shampoo in clinical studies
[51]
.
Dermatologic Effects
Clobetasol Propionate
Acne
a) Acne has commonly been reported in patients treated with
clobetasol propionate shampoo in clinical studies
[51]
.
Acneiform eruption
a) Acneiform eruptions have been reported with the
application of topical corticosteroids such as clobetasol
propionate
[52]
[43]
[49]
[53]
[51]
[50]
.
Allergic contact dermatitis
a) Allergic contact dermatitis has been reported with the
application of topical corticosteroids such as clobetasol
propionate. Patch testing is recommended to confirm
diagnosis in lesions that fail to heal
[52]
[43]
[49]
[53]
[51]
[50]
.
b) In a multicenter study that included sites in Denmark,
Portugal, Ireland, Belgium, France, Germany, Finland,
Sweden, the Netherlands, and the United Kingdom (n=7238),
189 (2.6%) patients developed contact sensitivity to one or
more topical corticosteroids. The following number of
reactions occurred for each drug: (1) budesonide 0.1%, 100
reactions, (2) hydrocortisone-17-butyrate, 74 reactions, (3)
clobetasol, 21 reactions, and (4) betamethasone valerate, 8
reactions. Since many patients had used corticosteroids
previously, it is difficult to determine whether the sensitivity
was to the tested agent or a cross-sensitivity to previously
used agents. Sensitivity was determined via patch tests; all of
the drugs were mixed in petrolatum except hydrocortisone
which was mixed in ethanol
[63]
.
c) Two cases of contact allergy to clobetasol propionate were
reported, and confirmed by positive patch test
[64]
. A literature review of clobetasol propionate contact allergy
was undertaken. It was shown that nearly half the subjects
also had positive patch tests to at least one other topical
corticosteroid formulation. Hypersensitivity should be
suspected in cases of treatment failure or paradoxical
worsening of dematosis. Two cases of contact dermatitis to
clobetasol are reported and a review of the literature on
corticosteroid-induced contact dermatitis provided
[65]
. A case of an allergic reaction to the 10% sorbitan
sesquioleate present in the ointment was reported. There
was no reaction to clobetasol propionate upon patch testing
[66]
.
Alopecia
a) Hair loss occurred in 1 of 294 patients with the topical
application of clobetasol propionate solution for the scalp
[43]
.
b) Alopecia has commonly been reported in patients treated
with clobetasol propionate shampoo in clinical studies
[51]
.
Application site pigmentation changes
a) Incidence: 1%
[53]
b) Pigmentation changes at the application site occurred in
1% of patients treated with clobetasol propionate topical
spray (n=120) compared with 0% of patients treated with
vehicle spray (n=120) in controlled clinical trials
[53]
.
Application site reaction
a) Incidence: 1.6%
[52]
b) Application-site reaction occurred in 1.6% of patients with
atopic dermatitis and psoriasis treated with clobetasol
propionate foam in controlled clinical studies (n=821). Most
cases were rated as mild to moderate
[52]
.
Asteatotic eczema
a) Incidence: 2%
[53]
b) Eczema asteatotic was reported in 2% of patients treated
with clobetasol propionate topical spray (n=120) compared
with 0% of patients treated with vehicle spray (n=120) in
controlled clinical trials
[53]
.
Atrophic condition of skin
a) Incidence: 1.9% to 4.2%
[52]
[50]
b) Application-site atrophy occurred in 1.9% of patients with
atopic dermatitis and psoriasis treated with clobetasol
propionate foam in controlled clinical studies (n=821). Most
cases were rated as mild to moderate
[52]
.
c) Skin atrophy was reported in 4.2% of patients treated with
clobetasol propionate lotion 0.05% twice daily for 2 or 4
weeks in pooled data from 2 clinical trials of patients with
moderate to severe atopic dermatitis and plaque psoriasis
[50]
.
d) In clinical studies, skin atrophy was reported with topical
application of clobetasol propionate cream and ointment
[49]
.
e) Skin atrophy has commonly been reported in patients
treated with clobetasol propionate shampoo in clinical studies
[51]
.
f) Application of clobetasol 0.05% ointment daily for 16 days
resulted in skin atrophy (eg, decrease in skin thickness of
about 12%). Continued intermittent administration at intervals
of every 5, 7, 10, or 14 days resulted in a plateau effect on
skin atrophy. With longer intervals between applications, skin
thickness increased but not back to baseline. This study was
designed to evaluate the effect of continuous followed by
intermittent application of a potent topical corticosteroid on
skin atrophy. In dermatology, continuous application for a few
weeks is used to induce remission followed by intermittent
application to maintain a remission
[62]
.
Burning sensation
a) Burning and stinging sensation was reported in 29 of 294
patients with topical application of clobetasol propionate
solution for the scalp
[43]
b) In a clinical studies, burning sensation was reported in
1.8% of patients with the topical application of clobetasol
propionate gel
[49]
.
c) In clinical studies, burning and stinging sensation was
reported in 1% of patients with the topical application of
clobetasol propionate cream
[49]
.
d) In clinical studies, burning sensation was reported in 0.5%
of patients with the topical application of clobetasol
propionate ointment
[49]
.
e) Burning at the application site occurred in 40% of patients
treated with clobetasol propionate topical spray (n=120)
compared with 47% of patients treated with vehicle spray
(n=120) in controlled clinical trials
[53]
.
f) Burning and stinging was reported in patients treated with
clobetasol propionate lotion 0.05% in controlled clinical trials
[50]
.
g) Burning and stinging was reported with the topical
application of clobetasol propionate shampoo in clinical
studies
[51]
.
Dermatitis
a) Dermatitis occurred in 1 of 294 patients with the topical
application of clobetasol propionate solution for the scalp
[43]
.
Discomfort, Skin
a) Incidence: 1.3%
[50]
b) Skin discomfort was reported in 1.3% of patients treated
with clobetasol propionate lotion 0.05% twice daily for 2 or 4
weeks in pooled data from 2 clinical trials of patients with
moderate to severe atopic dermatitis and plaque psoriasis
[50]
.
Dry skin
a) Incidence: 1% to 2%
[53]
[50]
b) Dry skin was reported in 1% of patients treated with
clobetasol propionate lotion 0.05% twice daily for 2 or 4
weeks in pooled data from 2 clinical trials of patients with
moderate to severe atopic dermatitis and plaque psoriasis
[50]
.
c) Dryness at the application site occurred in 2% of patients
treated with clobetasol propionate topical spray (n=120)
compared with 0% of patients treated with vehicle spray
(n=120) in controlled clinical trials
[53]
.
d) Dry skin has commonly been reported in patients treated
with clobetasol propionate shampoo in clinical studies
[51]
.
Erythema
a) Erythema was reported in patients treated with clobetasol
propionate lotion 0.05% in controlled, clinical trials
[50]
.
Fissure in skin
a) In clinical studies, skin cracking and fissuring occurred with
the topical application of clobetasol propionate cream and gel
[49]
.
Folliculitis
a) Folliculitis occurred in 2 of 294 patients with the topical
application of clobetasol propionate solution for the scalp
[43]
b) In clinical studies, folliculitis was reported with the
application of clobetasol propionate topical ointment
[49]
c) Folliculitis was reported in patients treated with clobetasol
propionate lotion 0.05% in controlled clinical trials
[50]
.
d) Folliculitis has commonly been reported in patients treated
with clobetasol propionate shampoo in clinical studies
[51]
.
Irritant contact dermatitis
a) Irritant dermatitis has commonly been reported in patients
treated with clobetasol propionate shampoo in clinical studies
[51]
.
Miliaria
a) Miliaria has been reported with the application of topical
corticosteroids such as clobetasol propionate
[53]
[51]
[50]
.
Perioral dermatitis
a) Perioral dermatitis has been reported with the application
of topical corticosteroids such as clobetasol propionate
[52]
[43]
[49]
[53]
[51]
[50]
.
Pruritus
a) Incidence: 0.5% to 3%
[49]
[51]
[53]
b) Itching and tightness of the scalp was reported in 1 of 294
patients with topical application of clobetasol propionate
solution for the scalp
[43]
.
c) In clinical studies, itching was reported with the topical
application of clobetasol propionate cream
[49]
.
d) In clinical studies, itching was reported in 0.5% of patients
with the topical application of clobetasol propionate ointment
[49]
.
e) Pruritus at the application site occurred in 3% of patients
treated with clobetasol propionate topical spray (n=120)
compared with 3% of patients treated with vehicle spray
(n=120) in controlled clinical trials
[53]
.
f) Pruritus was reported during clinical trials in patients
treated with clobetasol propionate lotion 0.05%
[50]
.
Psoriasis
a) Generalized pustular psoriasis associated with withdrawal
of clobetasol therapy occurred in psoriatic patients receiving
more than 50 g/wk for 2 weeks
[67]
.
b) Two cases of general pustular psoriasis were reported
following withdrawal of topical clobetasol propionate therapy
for psoriasis . Both patients showed initial improvement
followed by a worsening of the psoriasis and an increase in
inflammation and pustule formation. In the first case,
clobetasol therapy had been discontinued for 6 weeks when
psoriasis showed widespread annular lesions and
pustulation. In the second case, psoriasis flared up with
extensive pustulation 1 month after clobetasol had been
stopped. Active pustulation stopped at 2 and 3 weeks,
respectively, and methotrexate/azathioprine therapy
produced further improvement
[68]
.
c) Clobetasol propionate 0.1% was applied topically in a dose
of approximately 40 g/day to a 61-year-old woman with
psoriasis. Following initial improvement in the patient's
condition, pustules formed, which spread outwards from
flexures. They were associated with erythroderma,
intermittent fever, rigors, and gross local edema. Adrenal
suppression also occurred
[69]
.
Pustule, Scalp
a) Scalp pustules occurred in 3 of 294 patients with the
topical application of clobetasol propionate solution for the
scalp
[43]
.
Skin hypopigmented
a) Hypopigmentation has been reported with the application
of topical corticosteroids such as clobetasol propionate
[53]
[51]
[50]
.
Skin irritation
a) Incidence: 0.5% to 1%
[49]
[53]
b) In clinical studies, skin irritation was reported in 0.5% of
patients with the topical application of clobetasol propionate
ointment
[49]
.
c) Irritation at the application site occurred in 1% of patients
treated with clobetasol propionate topical spray (n=120)
compared with 0% of patients treated with vehicle spray
(n=120) in controlled clinical trials
[53]
.
d) Irritation was reported in patients treated with clobetasol
propionate lotion 0.05% in controlled, clinical trials
[50]
.
e) Discontinue clobetasol propionate therapy if irritation
develops
[52]
[43]
[49]
[51]
.
Skin striae
a) Striae have been reported with the application of topical
corticosteroids such as clobetasol propionate
[52]
[43]
[49]
[53]
[51]
[50]
.
Skin tenderness
a) Tenderness occurred in 1 of 294 patients with the topical
application of clobetasol propionate solution for the scalp
[43]
.
Stinging of skin
a) Burning or stinging sensation was reported in 29 of 294
patients with topical application of clobetasol propionate
solution for the scalp
[43]
.
b) In clinical studies, burning and stinging sensation was
reported in 1% of patients with the topical application of
clobetasol propionate cream
[49]
.
c) In clinical studies, stinging was reported with the topical
application of clobetasol propionate ointment
[49]
.
d) Burning and stinging was reported in patients treated with
clobetasol propionate lotion 0.05% in controlled clinical trials
[50]
.
e) Burning and stinging was reported with the topical
application of clobetasol propionate shampoo in clinical
studies
[51]
.
Telangiectasia
a) Incidence: 3.2%
[50]
b) Telangiectasia was reported in 3.2% of patients treated
with clobetasol propionate lotion 0.05% twice daily for 2 or 4
weeks in pooled data from 2 clinical trials of patients with
moderate to severe atopic dermatitis and plaque psoriasis
[50]
.
c) In clinical studies, telangiectasia has occurred with the
topical application of clobetasol propionate ointment
[49]
.
d) Telangiectasia has commonly been reported in patients
treated with clobetasol propionate shampoo in clinical studies
[51]
.
Tingling of skin
a) Tingling occurred in 2 of 294 patients with the topical
application of clobetasol propionate solution for the scalp
[43]
.
Urticaria
a) Urticaria has commonly been reported in patients treated
with clobetasol propionate shampoo in clinical studies
[51]
.
Endocrine/Metabolic Effects
Clobetasol Propionate
Cushing's syndrome
a) Cushing syndrome has been reported following the
systemic absorption of topical corticosteroids such as
clobetasol propionate
[52]
[43]
[49]
[53]
[51]
[50]
and was reported during postmarketing surveillance of 0.05%
clobetasol propionate lotion and shampoo
[50]
[51]
.
Delayed growth and development
a) Linear growth retardation and delayed weight gain have
been reported in children treated with topical corticosteroids
such as clobetasol propionate
[50]
[52]
[43]
[49]
[53]
[51]
.
Diabetes mellitus
a) The unmasking of latent diabetes mellitus has been
reported following systemic absorption of topical
corticosteroids such as clobetasol propionate
[52]
.
Hyperglycemia
a) Hyperglycemia has been reported following the systemic
absorption of topical corticosteroids such as clobetasol
propionate
[50]
[52]
[43]
[49]
[53]
[51]
.
Secondary hypocortisolism
a) Summary
1) Reversible hypothalamic-pituitary-adrenal (HPA) axis
suppression has occurred following systemic absorption of
topical corticosteroids
[52]
[43]
[49]
[53]
[51]
[50]
. An increased incidence of HPA axis suppression may be
observed with use of the more potent corticosteroids, use of
medication over a large surface area, prolonged use, the
addition of occlusive dressings, and coexisting hepatic failure
[52]
[50]
[53]
[51]
. Additionally, higher skin surface to body mass ratios place
pediatric patients at higher risk for HPA axis suppression
than adults
[52]
[43]
[49]
[53]
[51]
[50]
. Periodic evaluation for HPA axis suppression may be
necessary. The diagnosis of HPA axis suppression warrants
gradual withdrawal of clobetasol propionate therapy,
decreased dosage, or substitution of a less potent steroid.
Following discontinuation of the drug, recovery of the HPA
axis is usually prompt and complete. Rarely, steroid
withdrawal symptoms occur and require supplemental
systemic corticosteroids
[52]
[43]
[49]
[53]
[51]
[50]
.
b) Incidence: adult, 15% to 20%
[52]
[53]
; pediatric, 42% to 47%
[52]
[51]
c) Adults
1) In a clinical study of patients with atopic dermatitis
covering at least 30% of the body, HPA axis suppression
occurred in 16.2% of patients (6 of 37) 12 years or older
following 2 weeks of topical clobetasol propionate foam
treatment applied twice daily. Cortisol levels of all HPA axissuppressed patients had returned to normal upon testing 4
weeks after treatment. HPA axis suppression included serum
cortisol levels of 18 mcg/dL or less, as measured 30 minutes
post-cosyntropin stimulation
[52]
.
2) HPA suppression has occurred with clobetasol propionate
0.05% cream, gel, or ointment doses as low as 2 g daily
[43]
[49]
.
3) In a clinical study of patients with moderate to severe
atopic dermatitis, adrenal suppression occurred in 5 of 9
patients following 2 weeks of topical clobetasol propionate
lotion treatment. Suppression remained after 7 days in 1 of 3
patients who had follow-up testing
[50]
.
4) In a clinical study of patients with moderate to severe
plaque psoriasis, adrenal suppression occurred in 8 of 10
patients following 4 weeks of topical clobetasol propionate
lotion treatment. Suppression remained after 8 days in 1 of 2
patients who had follow-up testing
[50]
.
5) In a clinical study of patients with plaque psoriasis
covering at least 20% of the body, HPA axis suppression
occurred in 15% of patients (2 of 13) following 4 weeks of
topical clobetasol propionate spray treatment applied twice
daily. Cortisol levels of HPA axis-suppressed patients
returned to normal after therapy stopped. HPA axis
suppression included serum cortisol levels of 18 mcg/dL or
less, as measured by the cosyntropin stimulation test
[53]
.
6) In a clinical study of patients with plaque psoriasis
covering at least 20% of the body, HPA axis suppression
occurred in 19% (4 of 21) and 20% (3 of 15) of patients
treated for 2 and 4 weeks, respectively, with topical
clobetasol propionate 0.05% spray treatment applied twice
daily. Cortisol levels of HPA axis-suppressed patients
returned to normal after therapy stopped. HPA axis
suppression included serum cortisol levels of 18 mcg/dL or
less, as measured by the cosyntropin stimulation test
[53]
.
7) Adrenal suppression was also reported during
postmarketing surveillance of 0.05% clobetasol propionate
lotion and shampoo
[50]
[51]
.
8) Clobetasol 0.05% cream 3 times daily for 2 weeks
produced suppression of morning cortisol concentrations
(below 5 mcg/dL) in significantly more patients than those
receiving fluocinonide 0.05% cream
[54]
.
9) Adrenal suppression caused by 3 ointments was
compared in 24 normal male volunteers. Results
demonstrated that clobetasol propionate 0.05% produced
greater adrenal suppression than did diflorasone diacetate
PG 0.05%, which produced greater suppression than did
fluocinonide 0.05%. Adrenal suppression caused by
fluocinonide 0.05% was about equal to placebo. The drugs
were applied to about 75% of the body surface area once a
day for 6 days at a dose of 10 g/m(2). During the medication
phase, serum cortisol levels for clobetasol patients were as
low as 1 mcg/dL (normal 5 to 10 mcg/dL)
[55]
.
10) Absorption of clobetasol propionate was shown to be
significantly reduced by the use of d-N-butyl-adipate (instead
of propylene glycol) as a vehicle for the ointment and cream,
without significantly affecting topical vasoconstrictor potency.
Administration of the new preparation at 15 g daily for 12
days did not depress plasma cortisol levels; however, marked
depression was observed with the propylene glycol
preparation (Dermovate(R))
[56]
.
11) In a double-blind, vehicle-controlled study of clobetasol
0.05% scalp application in 378 patients, subnormal morning
plasma cortisol values were reported in 5% of patients
receiving the active drug and in 5% of those receiving the
vehicle alone. A 50% or greater decrease in morning cortisol
occurred in the patients receiving the active drug after 2
weeks of therapy vs 5% in the control group. Most of the
depressed plasma cortisol levels returned to normal even
during continued treatment. Within 1 week of discontinuing
therapy, all patients had normal plasma cortisol levels
[57]
.
d) Pediatrics
1) HPA axis suppression occurred in 47% of patients (7 of
15) ages 6 to 11 years following 2 weeks of topical clobetasol
propionate foam treatment applied twice daily. Serum cortisol
levels in all HPA axis-suppressed patients returned to normal
4 weeks after treatment
[52]
.
2) HPA axis suppression occurred in 42% of patients (5 of
12) ages 12 to 17 years following 4 weeks of topical
clobetasol propionate shampoo treatment applied once daily.
One HPA axis-suppressed patient who was tested after
treatment recovered after 2 weeks
[51]
.
3) Adrenal suppression occurred in 9 of 14 patients ages 12
to 17 years following 2 weeks of topical clobetasol propionate
lotion treatment twice daily for atopic dermatitis covering at
least 20% of the total body surface area. One of 4 patients
who were retested after treatment remained suppressed after
2 weeks
[50]
.
Immunologic Effects
Clobetasol Propionate
Immune hypersensitivity reaction
a) Corticosteroids, because of their anti-inflammatory effects,
often mask the clinical signs of contact dermatitis to a
corticosteroid preparation. Corticosteroid-sensitive patients
usually present with symptoms of chronic eczema which fails
to respond to therapy. Due to the reported failure of therapy,
the physician often prescribes a more potent corticosteroid
which may cause additional side effects and possibly
systemic effects. Topical corticosteroids also often mask
patch-test reactions obtained with the corticosteroid
molecules
[71]
.
Musculoskeletal Effects
Clobetasol Propionate
Osteoporosis
a) A case of osteonecrosis of both femoral heads and
osteoporosis occurred in a 51-year-old woman following the
long-term use of 0.05% clobetasol propionate ointment for
psoriasis of 26 years. The patient had used an average of 60
g/week for 5 years and was reported to have never received
systemic corticosteroids and had no clinical evidence of
hyperadrenocorticism. Plasma cortisol at 8 am was normal.
However, the patient also had a significant past history of
alcohol abuse which may have contributed to the
osteonecrosis
[70]
.
Neurologic Effects
Clobetasol Propionate
Headache
a) Incidence: 1.8%
[51]
b) Headache occurred in 1 of 294 patients with the topical
application of clobetasol propionate solution for the scalp
[43]
.
c) In phase 2 and 3 clinical trials in patients with moderate to
severe scalp psoriasis, headache occurred in 1.8% of
patients treated with clobetasol propionate shampoo (n=558)
compared with 0.8% of patients treated with vehicle shampoo
(n=127)
[51]
.
Intracranial hypertension, acute
a) Intracranial hypertension has been reported in children
treated with topical corticosteroids, such as clobetasol
propionate, manifesting with headaches, bilateral
papilledema, and bulging fontanelles
[52]
[43]
[49]
[53]
[51]
[50]
.
Numbness of finger
a) Numbness of fingers was reported with the application of
clobetasol propionate topical ointment in controlled clinical
studies
[49]
.
Ophthalmic Effects
Clobetasol Propionate
Eye irritation
a) Eye irritation occurred in 1 of 294 patients with topical
application of clobetasol propionate solution for the scalp
[43]
.
Raised intraocular pressure
a) Elevated intraocular pressure has occurred within days to
weeks after starting topical corticosteroid therapy and is
generally reversed within 1 to 2 months after discontinuing
the corticosteroid. The onset may be very rapid and severe,
resembling that of acute glaucoma. Low-potency
corticosteroids (hydrocortisone, dexamethasone,
flumethalone, prednisolone, methylprednisolone) are
recommended for use on the eyelid and periorbital area, with
discontinuation of therapy following clearing of the
dermatological condition
[58]
.
b) Topical application of corticosteroids to the eye may
induce intraocular pressure elevation in approximately 30%
of patients receiving this type of therapy
[59]
. This condition most frequently develops following
application of solutions. Ocular penetration of topical
corticosteroid ointments to the eyelids has resulted in
glaucomatous changes
[60]
[61]
.
Renal Effects
Clobetasol Propionate
Glycosuria
a) Glucosuria has been reported following systemic
absorption of topical corticosteroids such as clobetasol
propionate
[50]
[43]
[49]
[53]
[51]
.
Respiratory Effects
Clobetasol Propionate
Nasopharyngitis
a) Incidence: 5%
[53]
b) Nasopharyngitis occurred in 5% of patients treated with
clobetasol propionate topical spray (n=120) compared with
3% of patients treated with vehicle spray (n=120) in
controlled clinical trials
[53]
.
Streptococcal pharyngitis
a) Incidence: 1%
[53]
b) Streptococcal pharyngitis occurred in 1% of patients
treated with clobetasol propionate topical spray (n=120)
compared with 0% of patients treated with vehicle spray
(n=120) in controlled clinical trials
[53]
.
Upper respiratory infection
a) Incidence: 8%
[53]
b) Upper respiratory tract infection occurred in 8% of patients
treated with clobetasol propionate topical spray (n=120)
compared with 2% of patients treated with vehicle spray
(n=120) in controlled clinical trials
[53]
.
Other
Clobetasol Propionate
Secondary infection
a) Secondary infections have been reported with the
application of topical corticosteroids such as clobetasol
propionate. If an infection develops, treat with an appropriate
antimicrobial or antifungal medication; therapy with clobetasol
propionate may need to be suspended until the infection is
controlled
[52]
[43]
[49]
[53]
[51]
[50]
.
b) Infections and infestations have occurred in 14% of
patients treated with clobetasol propionate topical spray
(n=120) compared with 10% of patients treated with vehicle
spray (n=120) in controlled clinical trials
[53]
.
Teratogenicity/Effects in Pregnancy/Breastfeeding
A) Teratogenicity/Effects in Pregnancy
1) U.S. Food and Drug Administration's Pregnancy Category: Category C (All
Trimesters)
a) Either studies in animals have revealed adverse effects on the fetus
(teratogenic or embryocidal or other) and there are no controlled studies in
women or studies in women and animals are not available. Drugs should be given
only if the potential benefit justifies the potential risk to the fetus.
See Drug Consult reference:
PREGNANCY RISK CATEGORIES
2) Crosses Placenta: Unknown
3) Clinical Management
a) There are no adequate or well controlled studies of clobetasol use during
human pregnancy. Currently there are no data on the use of clobetasol in
pregnant women and the safe use of topical corticosteroids in pregnancy has not
been established. The effects, if any, on the developing fetus are unknown.
During animal studies, administration of subQ clobetasol, at doses up to 0.003
times the recommended human topical dose, resulted in fetotoxicity and
teratogenic effects. Clobetasol has a greater teratogenic potential than some less
potent steroids. Due to the lack of human safety information, the manufacturer
recommends the use of clobetasol during pregnancy only if the potential maternal
benefit outweighs the potential fetal risk
[1]
.
4) Literature Reports
a) There are no adequate or well controlled studies of clobetasol use in human
pregnancy. During animal studies, administration of corticosteroids, at relatively
low levels, has resulted in teratogenic effects. Administration of subQ clobetasol
0.03 to 1 mg/kg (approximately 0.01 and 0.33 times the human topical dose,
respectively) to mice resulted in fetotoxicity and teratogenicity, including cleft
palate and skeletal abnormalities. In pregnant rabbits, administration of clobetasol
3 and 10 mcg/kg (approximately 0.001 and 0.003 times the human topical dose,
respectively) resulted in teratogenic effects such as cleft palate, cranioschisis,
and skeletal abnormalities
[1]
.
B) Breastfeeding
1) Micromedex Lactation Rating: Infant risk cannot be ruled out.
a) Available evidence and/or expert consensus is inconclusive or is inadequate
for determining infant risk when used during breastfeeding. Weigh the potential
benefits of drug treatment against potential risks before prescribing this drug
during breastfeeding.
2) Clinical Management
a) Lactation studies with clobetasol have not yet been conducted. No reports
describing the use of clobetasol during human lactation are available and the
effects on the nursing infant from exposure to the drug in milk are unknown.
Systemic corticosteroids are detectable in small quantities in breast milk and may
cause adverse effects (eg, growth suppression). It is unknown if topical
corticosteroid administration can result in systemic absorption. Because many
drugs are excreted in human milk, the manufacturer recommends the use of
caution when prescribing topical corticosteroids to a nursing woman
[1]
.
Drug Interactions
Drug-Drug Combinations
Glycerol Phenylbutyrate
1) Interaction Effect: increased plasma ammonia levels
2) Summary: Use of a corticosteroid may cause increased plasma
ammonia levels due to the breakdown of body protein. Closely
monitor ammonia levels with concurrent use of glycerol
phenylbutyrate and corticosteroids
[72]
.
3) Severity: moderate
4) Onset: unspecified
5) Substantiation: theoretical
6) Clinical Management: The use of a corticosteroid may cause
increased plasma ammonia levels from the breakdown of body
protein. If coadministration of glycerol phenylbutyrate and a
corticosteroid is required, closely monitor ammonia levels
[72]
.
7) Probable Mechanism: increased protein catabolism by
corticosteroids
Pixantrone
1) Interaction Effect: decreased exposure of pixantrone
2) Summary: Concurrent administration of pixantrone (a Pglycoprotein (P-gp) substrate) and a P-gp inducer may decrease the
exposure of pixantrone. If concurrent administration of pixantrone
and a P-gp inducer is required, additional caution is recommended
[73]
.
3) Severity: major
4) Onset: unspecified
5) Substantiation: theoretical
6) Clinical Management: Concurrent administration of pixantrone (a
P-glycoprotein (P-gp) substrate) and a P-gp inducer may decrease
the exposure of pixantrone. If concurrent administration of
pixantrone and a P-gp inducer is required, additional caution is
recommended
[73]
.
7) Probable Mechanism: induction of P-glycoprotein-mediated efflux
transport of pixantrone
CLINICAL APPLICATIONS
Monitoring Parameters
A) Clobetasol Propionate
1) Therapeutic
a) Physical Findings
1) Corticosteroid-Responsive Dermatosis
a) Reduced inflammation and/or pruritus may indicate efficacy.
2) Moderate-to-Severe Plaque-Type Psoriasis
a) Improvement in lesions and/or control of disease may indicate efficacy.
2) Toxic
a) Laboratory Parameters
1) Consider periodic evaluation for adrenal suppression (eg, adrenocorticotropic
hormone (ACTH) stimulation test, morning cortisol level), especially in pediatric
patients, and when used over large surface areas, over prolonged periods, under
occlusion, on an altered skin barrier, and in patients with liver failure
[1]
.
Patient Instructions
A) Clobetasol Propionate (On the skin)
Clobetasol Propionate
Treats skin problems such as psoriasis, skin irritation, and allergic reactions. This
medicine is a corticosteroid.
When This Medicine Should Not Be Used:
Do not use this medicine if you have had an allergic reaction to clobetasol.
How to Use This Medicine:
Cream, Foam, Gel/Jelly, Liquid, Lotion, Ointment, Shampoo, Spray
Take your medicine as directed.
Use this medicine only on your skin. Rinse it off right away if it gets on a cut or
scrape. Do not get the medicine in your eyes, nose, or mouth.
Do not cover, wrap, or wear tight fitting clothes over your treated skin areas
unless directed by your doctor. Allow the cream or liquid to dry before putting on
your clothes.
Cream, shampoo, or spray: Do not use this medicine on your face, armpits, or
groin area unless your doctor tells you to.
Shampoo: Apply the shampoo to your dry scalp. Part your hair so that you only
treat the affected areas. Apply a small amount to the area, massage gently, and
leave it on for 15 minutes. Add water, lather, and rinse well.
Wash your hands with soap and water before and after you use this
medicine.Make sure your skin is clean and dry before you apply this medicine.
Apply a thin layer of the medicine to the affected area. Rub it in gently.
Do not inhale this medicine or use it near heat or an open flame. Do not puncture,
break, or burn the aerosol can.
It is very important that you keep using this medicine for the full time of treatment
to help clear up your skin or scalp problem completely . Do not miss any doses.
This medicine is not for long-term use.Do not use this medicine for more than 2
weeks at a time unless directed by your doctor. Tell your doctor if you skin
condition does not improve within 2 weeks.
If a Dose is Missed:
Apply a dose as soon as you can. If it is almost time for your next dose, wait until
then and apply a regular dose. Do not apply extra medicine to make up for a
missed dose.
How to Store and Dispose of This Medicine:
Store the medicine in a closed container at room temperature, away from heat,
moisture, and direct light. Do not refrigerate or freeze.
Ask your pharmacist or doctor how to dispose of the medicine container and any
leftover or expired medicine.
Keep all medicine out of the reach of children. Never share your medicine with
anyone.
Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including overthe-counter medicines, vitamins, and herbal products.
This medicine should not be used together with other corticosteroid medicines,
such as betamethasone, hydrocortisone, triamcinolone, Cortaid®, or Lotrisone®,
unless directed by your doctor.
Warnings While Using This Medicine:
Make sure your doctor knows if you are pregnant or breastfeeding, or if you have
liver disease, Cushing disease, diabetes, or a skin infection.
This medicine may increase your risk of adrenal gland problems. The risk is
greater for children and patients who use large amounts of medicine or use it for a
long time. Talk to your doctor about the symptoms you should watch for. Some
possible symptoms are dizziness or lightheadedness, unusual tiredness or
weakness, feeling cold, loss of appetite, puffy face, and thin skin that bruises
easily.
Tell your doctor right away if your skin becomes very irritated, dry, red, or swollen
or starts to itch or burn. These may be signs of an infection.
Do not use this medicine to treat a skin problem your doctor has not examined.
Tell any doctor or dentist who treats you that you are using this medicine. You
may need to stop using this medicine several days before you have surgery or
medical tests.
Your doctor will check your progress and the effects of this medicine at regular
visits. Keep all appointments.Call your doctor if your skin problem is not better
within 2 weeks.
Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:
Allergic reaction: Itching or hives, swelling in your face or hands, swelling or
tingling in your mouth or throat, chest tightness, trouble breathing
Color changes on the skin, dark freckles, easy bruising, muscle weakness
Round, puffy face
Weight gain around your neck, upper back, breast, face, or waist
Burning, pain, redness, or thinning of the skin
Dizziness or lightheadedness
Fever, cough, runny nose, sore throat
Increase in thirst or how often you urinate
If you notice these less serious side effects, talk with your doctor:
Mild acne, pain, redness, swelling, or burning on the application site
Swollen hair pores, excess hair growth
If you notice other side effects that you think are caused by this medicine, tell your
doctor.
Place In Therapy
A) Clobetasol propionate is the most potent corticosteroid available in the United
States
[101]
[12]
. It has been more effective than fluocinonide, betamethasone, and halcinonide in
the treatment of psoriasis and eczema. From results of clinical trials, clobetasol
has been shown to be very effective. It should be considered for admission to
hospital formularies for the treatment of severe and/or refractory dermatoses.
B) Guidelines for the selection and use of topical corticosteroids have been
developed by a Committee of the American Academy of Dermatology
[102]
. Low-to-medium potency agents are usually effective for treating thin, acute,
inflammatory skin lesions; whereas, high or super-potent agents are often
required for treating chronic, hyperkeratotic, or lichenified lesions. Since the
stratum corneum is thin on the face and intertriginous areas, low-potency agents
are preferred but a higher potency agent may be used for 2 weeks. Because the
palms and soles have a thick stratum corneum, high or super-potent agents are
frequently required. Low potency agents are preferred for infants and the elderly.
Infants have a high body surface area to weight ratio; elderly patients have thin,
fragile skin.
C) Guidelines for the selection and use of topical corticosteroids have been
developed by a Committee of the American Academy of Dermatology
[102]
. The vehicle in which the topical corticosteroid is formulated influences the
absorption and potency of the drug. Ointment bases are preferred for thick,
lichenified lesions; they enhance penetration of the drug. Creams are preferred
for acute and subacute dermatoses; they may be used on moist skin areas or
intertriginous areas. Solutions, gels, and sprays are preferred for the scalp or for
areas where a non- oil-based vehicle is needed.
D) Guidelines for the selection and use of topical corticosteroids have been
developed by a Committee of the American Academy of Dermatology
[102]
. In general, super-potent agents should NOT be used for longer than 3 weeks
unless the lesion is limited to a small body area. Medium-to-high potency agents
usually cause only rare adverse effects when treatment is limited to 3 months or
less, and use on the face and intertriginous areas are avoided. If long-term
treatment is needed, intermittent versus continuous treatment is recommended.
E) Guidelines for the selection and use of topical corticosteroids have been
developed by a Committee of the American Academy of Dermatology
[102]
. Most preparations are applied once- or twice-daily. More frequent application
may be necessary for the palms or soles because the preparation is easily
removed by normal activity and penetration is poor due to a thick stratum
corneum. Every-other-day or weekend-only application may be effective for
treating some, chronic conditions.
Mechanism of Action / Pharmacology
A) MECHANSIM OF ACTION
1) SUMMARY
a) Clobetasol-17-propionate is a super-potent topical corticosteroid. It is a 21chloro-9-alpha-fluoro-corticosteroid, which derives its anti-inflammatory activity
from the 11-beta-hydroxy group. This activity is enhanced by a fluorine atom in
position 9 and a methyl group in position 16.
2) Corticosteroids have multiple mechanisms of action including anti-inflammatory
activity, immunosuppressive properties, and antiproliferative actions
[84]
[85]
. Anti-inflammatory effects result from decreased formation, release, and activity
of the mediators of inflammation (eg, kinins, histamine, liposomal enzymes,
prostaglandins, and leukotrienes). These effects reduce the initial manifestations
of the inflammatory process
[86]
[87]
[88]
. Corticosteroids inhibit margination and subsequent cell migration to the area of
injury, and also reverse the dilation and increased vessel permeability in the area,
resulting in decreased access of cells to the sites of injury. This vasoconstrictive
action decreases serum extravasation, swelling, and discomfort
[86]
. The immunosuppressive properties decrease the response to delayed and
immediate hypersensitivity reactions (eg, type III and type IV) (Ricciatti & Lester,
1977). This results from inhibition of the toxic effect from antigen and antibody
complexes that precipitate in vessel walls creating cutaneous allergic vasculitis,
and by inhibiting the action of lymphokines, target cells, and macrophages which
together produce allergic contact dermatitis reactions
[86]
. Additionally, the access of sensitized T lymphocytes and macrophages to target
cells may also be prevented by corticosteroids
[86]
. The antiproliferative effects reduce hyperplastic tissue formation characteristic of
psoriasis
[89]
[90]
[91]
.
3) The potency of topical corticosteroids is determined by the McKenzieStoughton vasoconstrictor assay
[92]
. The assay measures vasoconstriction, which is dependent on percutaneous
absorption, caused by an agent. When this assay was developed in the 1960s,
the correlation between vasoconstriction and clinical efficacy was considered to
be good
[93]
[94]
. However, clinical trials evaluating newer topical corticosteroids found differences
between results of the vasoconstrictor assay and the therapeutic outcome of 11
out of 17 preparations. Additional clinical trials using a single disease and rigid
criteria are needed to determine clinically relevant differences in efficacy, safety,
and cost
[95]
.
4) Three-month treatment with clobetasol propionate 0.05% cream in 10 women
with vulval lichen sclerosis et atrophicus modified the immunohistochemical
parameters of skin immune system activation
[96]
.
B) REVIEW ARTICLES
1) Guidelines regarding the use of topical corticosteroids, as well as suggestions
for prevention of their misuse and toxicity, are available
[97]
.
Therapeutic Uses
Clobetasol
Disorder of skin
See Drug Consult reference:
TOPICAL CORTICOSTEROIDS - DOSING GUIDELINES
Clobetasol Propionate
Chloasma
a) Overview
FDA Approval: Adult, no; Pediatric, no
Efficacy: Adult, Evidence is inconclusive
Recommendation: Adult, Class IIb
Strength of Evidence: Adult, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Effective in one small study of patients with melasma (n=7) treated
with clobetasol propionate
[25]
.
c) Adult:
1) Seven patients with melasma showed 80% to 90% clearance of
pigmentation after 6 to 8 weeks of treatment with clobetasol
propionate 0.05% cream applied twice daily for 4 weeks followed by
once daily for 4 weeks. Treatment was discontinued in 3 patients
because of local atrophy and telangiectasia. In 4 patients,
pigmentation reappeared 2 to 3 weeks after stopping treatment and
returned to the pretreatment state in four to six months
[25]
.
Disorder of skin
See Drug Consult reference:
TOPICAL CORTICOSTEROIDS - DOSING GUIDELINES
Disorder of skin, Corticosteroid responsive
FDA Labeled Indication
a) Overview
FDA Approval: Adult, yes (cream, emollient, foam, gel, lotion,
ointment); Pediatric, yes (age 12 years or older (cream, emollient,
foam, gel, ointment))
Efficacy: Adult, Effective; Pediatric, Effective
Recommendation: Adult, Class IIb; Pediatric, Class IIb
Strength of Evidence: Adult, Category B; Pediatric, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Clobetasol propionate is indicated for the short-term treatment (2
consecutive weeks or less) of inflammatory and pruritic
corticosteroid-responsive dermatoses
[1]
[2]
[3]
[4]
[5]
[6]
In a randomized study of 377 patients (12 years of age and older)
with moderate to severe atopic dermatitis, 52% of patients treated
with clobetasol propionate 0.05% foam topically twice daily for 2
weeks achieved treatment success compared with 14% of patients
treated with vehicle foam
[2]
c) Adult:
1) In a randomized study of 377 patients (12 years of age and older)
with moderate to severe atopic dermatitis, 52% (131 of 251) of
patients treated with clobetasol propionate 0.05% foam topically
twice daily for 2 weeks achieved treatment success compared with
14% (18 of 126) of patients treated with vehicle foam. The primary
endpoint was treatment success, defined by an Investigator's Static
Global Assessment (ISGA) score of clear (0) or almost clear (1) with
at least 2 grades improvement from baseline, and scores of absent
or minimal (0 or 1) for erythema and induration/papulation
[2]
.
2) Clobetasol is indicated for the short-term (2 weeks or less)
treatment of inflammatory and pruritic corticosteroid-responsive
dermatoses
[1]
[3]
[4]
[5]
. Other uses include eczema
[7]
and psoriasis (when used alone or in combination with ultraviolet
light)
[8]
[9]
[10]
[11]
. Clobetasol has demonstrated similar or superior efficacy to other
high-potency topical corticosteroids in treating psoriasis
[12]
[7]
and has been effective in refractory disease
[9]
[13]
. However, some investigators have found clobetasol's efficacy in
psoriasis to be questionable
[14]
[15]
[16]
.
3) Therapy-resistant chronic atopic dermatitis completely resolved in
44 of 48 patients treated with clobetasol propionate lotion once a
week under Duoderm(R) hydrocolloid dressing. Healing time ranged
from 8 days to 2.5 weeks, and 2 patients developed a mild folliculitis
[17]
.
4) Two patients with inflammatory linear verrucous epidermal nevi
(ILVEN) refractory to surgical excision or anthralin responded to
topical 0.05% clobetasol propionate under occlusive dressing with
or without salicylic acid
[18]
.
Hemangioma
a) Overview
FDA Approval: Adult, no; Pediatric, no
Efficacy: Pediatric, Evidence is inconclusive
Recommendation: Pediatric, Class III
Strength of Evidence: Pediatric, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Clobetasol treatment caused regression of capillary hemangiomas
and associated visual defects in 3 infants
[20]
.
c) Pediatric:
1) Clobetasol applied twice daily for 2 weeks with a 1-week drugfree interval produced regression of capillary hemangiomas on the
eyelids of 3 infants under 6 months of age. All of the infants
developed visual defects associated with enlargement of the tumor.
Clobetasol therapy was repeated until the tumor regressed
sufficiently to eliminate visual defects. In comparison to intralesional
injection of corticosteroids, the tumors regressed more slowly, but
the positive effect of clobetasol treatment continued after stopping
the drug. None of the infants developed adrenal suppression
[20]
.
Lichen sclerosus et atrophicus; Adjunct
a) Overview
FDA Approval: Adult, no; Pediatric, no
Efficacy: Adult, Evidence favors efficacy
Recommendation: Adult, Class IIb
Strength of Evidence: Adult, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Use of clobetasol propionate 0.05% cream brought complete
remission to 77% of 54 women with lichen sclerosus
[22]
.
Topical clobetasol significantly reduced the symptom severity of
penile lichen sclerosus et atrophicus (PLSA), in a retrospective
study (n=21)
[23]
.
Although clobetasol dipropionate 0.05% surpasses testosterone
propionate 2% in treating signs and symptoms of lichen sclerosus, it
still falls short of reliably curing this chronic cutaneous disorder of
the vulva
[24]
. In another study, symptoms of vulval lichen sclerosus were
alleviated in 13 patients treated with clobetasol propionate cream
0.05% for 12 weeks (Dalzial & Wojnarowska, 1993).
c) Adult:
1) Topical clobetasol significantly reduced the symptom severity of
penile lichen sclerosus et atrophicus (PLSA), in a retrospective
study. Twenty-two men with histologically confirmed PLSA had
received either topical clobetasol 0.05% cream as the initial
treatment regimen (n=13), or clobetasol as a secondary treatment
(n=9). Patients applied topical clobetasol 0.05% cream either once
or twice daily, for an average treatment duration of 7 weeks.
Significant reductions in the magnitude of most subjective
symptoms (frequency/severity of itching and burning, soreness,
erectile pain/discomfort, dyspareunia, urinary flow constriction and
foreskin tightness) were reported, either directly after the last dose
applied (p less than 0.001), or at long-term follow-up (p less than
0.01). Significant reductions were also observed in the histologic
manifestations of PLSA (hyperorthokeratosis, dermal inflammation,
epidermal atrophy and basal cell hydropic degeneration, p less than
0.05; dermal edema and collagen homogenization, p less than 0.01)
within biopsy samples of the 15 patients deemed histologically
evaluable. Nine patients were clinically free of PLSA at long-term
follow-up, yet 41% of all patients treated continued to report
persistence of diminished penile sensitivity after treatment
[23]
.
2) Although clobetasol dipropionate 0.05% surpasses testosterone
propionate 2% in treating signs and symptoms of lichen sclerosus,
unfortunately it still falls short of reliably curing this chronic
cutaneous disorder of the vulva
[24]
. Over a period of six years 40 women with the disorder were given
one of two instruction sets: to apply the testosterone ointment twice
daily for 3 months, once daily for another 3 months, and finally two
or three times a week; or to apply the clobetasol ointment twice daily
for 1 month, once daily for another month, and finally one or two
times a week. Short-term and long-term progress was noted at 3
months and 1 year, both subjectively by patients and objectively by
one gynecologist. At the first follow-up examination women in both
groups reported improvement, although objective signs differed
significantly between groups in favor of the clobetasol treatment.
Thereafter subjective and objective reports rated significantly more
improvement in the clobetasol-treated group. Patients in the two
groups stopped treatment for different reasons: Clobetasol-treated
patients because of improvement of the condition; testosteronetreated patients for lack of response. It is also notable that side
effects, mainly hyperandrogenism, occurred in 30% of women
treated with testosterone. However, 8 of 18 patients successfully
treated with clobetasol relapsed subjectively and objectively, and
required intermittent repeat treatment with clobetasol. Regression
analysis determined equivalency in baseline parameters between
groups in this observational study, although instructions to the two
groups differed in treatment interval, which raises compliance
questions.
3) Use of clobetasol propionate 0.05% cream brought complete
remission to 77% of 54 women with lichen sclerosus
[22]
. The women were recruited at one institution following a chart
review of patients with symptomatic, biopsy-proven disease and
treatments they had undertaken unsuccessfully; the average patient
had tried 2.25 treatment modalities (range, 1 to 13). After
enrollment, the treatment protocol was a standard regimen of
clobetasol propionate 0.05% cream twice daily for one month, then
at bedtime for one month, then twice a week for three months, and
then as needed one or two times per week. At the 3-month
evaluation, 76.8% of patients had complete remission of symptoms,
17.9% had partial remission, and 5.4% were unchanged. As to
clinical appearance, 31.5% of patients had complete remission,
46.3% had partial remission, and 22% were unchanged. In 3
patients, burning and hyperemia secondary to contact dermatitis
caused withdrawal from the study. Chi-square analysis of the
women's prior treatments indicated a variety of symptomatic
responses: Testosterone propionate 2% worked with erosions
(p=0.056) and thinning (p=0.01); steroids worked on tearing
(p=0.039) while petroleum jelly did not; and perineoplasty
procedures were unsuccessful in both treating tissue bridges and
erosions.
4) Symptoms of vulval lichen sclerosus were alleviated in 13
patients treated with clobetasol propionate cream 0.05% for 12
weeks. During a 39-month follow-up period, 4 women required
further treatment periods of between 1 and 4 weeks. There was no
evidence of steroid-induced atrophy, telangiectasia, striae, or
secondary infection (Dalzial & Wojnarowska, 1993).
Oral lichen planus
a) Overview
FDA Approval: Adult, no; Pediatric, no
Efficacy: Adult, Evidence favors efficacy
Recommendation: Adult, Class IIb
Strength of Evidence: Adult, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Clobetasol was effective in the treatment of atrophic and erosive
lesions of oral lichen planus
[21]
.
Plasma cortisol levels were unaffected by long-term topical use of
clobetasol
c) Adult:
1) Clobetasol propionate 0.05% ointment was effective in controlling
oral lichen planus, in a randomized, controlled, open- labeled clinical
trial. Patients with histologically confirmed oral lichen planus were
treated for 6 months with one the following regimens: fluocinonide
0.05% ointment with antimycotics applied 3 times daily for 2 months,
twice-daily for 2 months, and once daily thereafter (n=24);
clobetasol 0.05% ointment with antimycotics applied twice-daily for
the first 4 months, and then once-daily thereafter (n=25); placebo
plus antimycotics (n=11). All study drugs were formulated in a
hydroxyethyl cellulose medium for oral adhesion. Every patient
treated with clobetasol experienced some relief; 90% of patients
treated with fluocinonide also experienced improvement. Clobetasol
provided complete remission in 75% of patients compared with 25%
of patients receiving fluocinonide and none receiving placebo
(p=0.00442 and 0.00049, respectively). Clobetasol controlled
symptoms significantly better than fluocinonide and placebo
(p=0.00423 and 0.00041, respectively). Clobetasol was also more
effective in treating atrophic lesions compared with fluocinonide
(p=0.0044). Sixty-five percent of clobetasol patients were clinically
stable at 6-month follow-up compared with 55% of fluocinonide
patients. Oropharyngeal candidiasis was not observed; adverse
events were otherwise limited to alterations in sense of taste and
extrinsic staining of teeth, both attributed to concomitant use of
antimycotic agents during the study
[21]
.
Pemphigoid
a) Overview
FDA Approval: Adult, no; Pediatric, no
Efficacy: Adult, Evidence is inconclusive
Recommendation: Adult, Class IIb
Strength of Evidence: Adult, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Topical clobetasol propionate promoted remission in 7 patients (3
with pemphigus vulgaris, 4 with pemphigus foliaceus), with healing
of both cutaneous and mucosal lesions in an open-label,
prospective study
[29]
.
c) Adult:
1) Topical clobetasol propionate promoted clinical remission with
healing of dermal and mucosal lesions in pemphigus bullous
disease. In an open-label, prospective study, 7 patients (3 with
PEMPHIGUS vulgaris, 4 with pemphigus foliaceus) were treated
with clobetasol propionate 0.05% cream. All patients were classified
as having mild disease severity, based upon the criteria of having
fewer than 10 new bullous lesions per week and pemphigus
antibody titer less than or equal to 1:320. Clobetasol propionate
0.05% cream was applied twice daily (average of 10 g/day) to all
mucosal and skin lesions for a minimum of 15 days, followed by
progressive dosage tapering, to an average of 5 g/day.
Betamethasone valerate 0.1% cream was used for facial lesions,
and 1 patient required pharyngeal application of beclomethasone
spray. Healing of cutaneous lesions was observed within 15 days;
mucosal lesion healing required a minimum of 1 month. Relapse
was observed whenever dosage was reduced below 5 g/week, and
was usually reversed with an increase in application frequency.
Three patients with more severe relapses required administration of
systemic treatment. There were no serious side effects reported
[29]
.
Plaque psoriasis (Mild to Moderate)
FDA Labeled Indication
a) Overview
FDA Approval: Adult, yes; Pediatric, yes (12 years or older (Olux(R)
foam))
Efficacy: Adult, Evidence favors efficacy; Pediatric, Evidence favors
efficacy
Recommendation: Adult, Class IIb; Pediatric, Class IIb
Strength of Evidence: Adult, Category B; Pediatric, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Clobetasol propionate is indicated in patients 12 years or older for
the short-term (2 consecutive weeks or less) treatment of
inflammatory and pruritic corticosteroid-responsive dermatoses
[39]
In a randomized study of 376 patients (12 years of age or older) with
mild to moderate plaque-type psoriasis, 16% of patients treated with
clobetasol propionate 0.05% foam topically twice daily for 2 weeks
achieved treatment success compared with 4% of patients treated
with vehicle foam
[2]
Clobetasol foam is effective for treatment of mild to moderate
plaque-type psoriasis
[35]
Hyperproliferation-related keratin (K6) cell production in psoriasis
was profoundly suppressed by the application of clobetasol-17propionate lotion under hydrocolloid occlusive dressing, in an openlabel, prospective study
[36]
A 0.05% emollient formulation of clobetasol produced notably less
hypothalamic-pituitary-adrenal (HPA) axis suppression than the
0.05% cream formulation and was effective for use over a 4-week
period in the treatment of psoriasis
[38]
c) Adult:
1) Foam
a) In a randomized study of 376 patients (12 years of age and older)
with mild to moderate plaque-type psoriasis, 16% (41 of 253) of
patients treated with clobetasol propionate 0.05% foam topically
twice daily for 2 weeks achieved treatment success compared with
4% (5/123) of patients treated with vehicle foam. The primary
endpoint was treatment success, defined by an Investigator's Static
Global Assessment (ISGA) score of clear (0) or almost clear (1) with
at least 2 grades improvement from baseline, scores of none or
faint/minimal (0 or 1) for erythema and scaling, and a score of none
(0) for plaque thickness
[2]
.
b) Topical clobetasol, delivered as foam, is effective for treatment of
mild to moderate plaque-type psoriasis. Eighty-one patients with
psoriasis on nonscalp sites were randomized in a ratio of 3 to 1 to
receive clobetasol propionate foam or placebo foam. Components
of foam were 0.05% clobetasol propionate (absent in placebo foam)
in cetyl alcohol, stearyl alcohol, polysorbate 60, ethanol, purified
water, propylene glycol, citric acid, anhydrous potassium citrate and
a butane/propane propellant. Foam was applied twice daily for 2
weeks. In 2 weeks, 27% of clobetasol-treated patients showed
marked or better improvement, compared to 5% of the placebo
patients. The greater improvement was still evident 2 weeks after
termination of treatment. Pruritus was eliminated in 50% of
clobetasol-treated patients and in 20% of placebo- treated patients
(p less than 0.02). The composite score of signs of psoriasis
(erythema, scaling, plaque thickness) showed greater improvement
with clobetasol than with placebo. Thirty percent of subjects in each
group had adverse reactions that could have been related to the use
of the foam
[35]
.
2) Emollient
a) An emollient formulation of clobetasol produced notably less
hypothalamic-pituitary-adrenal (HPA) axis suppression than the
cream formulation, and was safe and effective for use over a 4week period in the treatment of psoriasis. This 2-phase
safety/efficacy study compared clobetasol 0.05% emollient with
0.05% cream (1.5 g) in 12 patients with psoriasis or eczema during
the safety phase. Only 1 patient in the emollient treatment group
developed serum cortisol levels less than 10 mcg/100 mL, versus 4
in the cream treatment group. In the efficacy phase, 89 patients with
moderate to severe plaque-type psoriasis (untreated for at least 2
weeks prior to study) received either clobetasol emollient (n=44) or
emollient vehicle (n=45) on a double-blind, randomized, parallelgroup basis. Study treatments were applied 30 minutes after bathing
to lesions anywhere on the body other than the face, scalp, axillae,
groin, or rectal area. Treatment was continued twice daily for 4
weeks, not to exceed 50 g/wk. The emollient treatment group had
significantly greater symptom and severity score improvement than
the vehicle group, and only mild to moderate local adverse events.
The emollient formulation of clobetasol may be clinically useful in
dermatoses requiring more that a 2-week therapy duration
[38]
.
3) Ointment
a) Clobetasol propionate 0.05% ointment applied twice daily for 2
weeks (less than 50 g/wk) promoted a dramatic reduction in
symptoms of psoriasis and a progressive reduction in affected body
surface area in 74 patients receiving up to 3 courses of treatment. A
minimum interval of one week was required between courses. Nine
patients (12%) had at least one abnormally low morning plasma
cortisol level during therapy, and there was a strong correlation
between percent body surface area treated and abnormal plasma
cortisol levels
[8]
.
b) In two small studies, clobetasol did not demonstrate therapeutic
advantage over placebo in the treatment of psoriasis. Ninety
patients were randomized to clobetasol, clobetasol with ultraviolet B
(UVB) light, or placebo and UVB. There were 21 dropouts in this
study. Among the remaining patients, combination clobetasol/UVB
did not cause a significant decrease in healing time when compared
with placebo/UVB, and single-agent clobetasol was less effective
than either of the other treatment groups
[15]
. There was no statistical difference in efficacy between clobetasol
0.05% ointment applied for 2 weeks and clobetasol applied once
daily for one week followed by placebo for one week in 12 psoriatic
patients
[14]
.
d) Pediatric:
1) Foam
a) In a randomized study of 376 patients (12 years of age and older)
with mild to moderate plaque-type psoriasis, 16% (41 of 253) of
patients treated with clobetasol propionate 0.05% foam topically
twice daily for 2 weeks achieved treatment success compared with
4% (5 of 123) of patients treated with vehicle foam. The primary
endpoint was treatment success, defined by an Investigator's Static
Global Assessment (ISGA) score of clear (0) or almost clear (1) with
at least 2 grades improvement from baseline, scores of none or
faint/minimal (0 or 1) for erythema and scaling, and a score of none
(0) for plaque thickness
[2]
.
Plaque psoriasis (Moderate to Severe)
FDA Labeled Indication
a) Overview
FDA Approval: Adult, yes (cream, emollient, lotion, spray); Pediatric,
yes ( 16 years or older (Embeline(R) E emollient, Temovate(R)-E
cream, emollient); 18 years or older (Clobex(R) lotion, spray))
Efficacy: Adult, Evidence favors efficacy; Pediatric, Evidence favors
efficacy
Recommendation: Adult, Class IIb; Pediatric, Class IIb
Strength of Evidence: Adult, Category B; Pediatric, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Temovate(R) E cream and Embeline(R) E emollient are indicated in
patients 16 years or older for treatment for up to 4 consecutive
weeks of moderate to severe plaque-type psoriasis
[1]
.
Clobex(R) spray and lotion are indicated for the treatment of adults
with moderate to severe plaque psoriasis
[32]
[6]
.
In a randomized study of 376 patients (12 years of age or older) with
mild to moderate plaque-type psoriasis, 16% of patients treated with
clobetasol propionate 0.05% foam topically twice daily for 2 weeks
achieved treatment success compared with 4% of patients treated
with vehicle foam
[2]
.
Clobetasol foam is effective for treatment of mild to moderate
plaque-type psoriasis
[35]
.
Hyperproliferation-related keratin (K6) cell production in psoriasis
was suppressed by the application of clobetasol-17-propionate
lotion under hydrocolloid occlusive dressing, in an open-label,
prospective study
[36]
.
A combination of 2 weeks of clobetasol propionate to promote rapid
healing, followed by 4 weeks of a nonsteroidal antipsoriatic
treatment for maintenance, has been shown to restore barrier
function of the skin in severe plaque psoriasis
[37]
.
A 0.05% emollient formulation of clobetasol produced less
hypothalamic-pituitary-adrenal (HPA) axis suppression than the
0.05% cream formulation and was effective for use over a 4-week
period in the treatment of psoriasis
[38]
.
c) Adult:
1) Emollient
a) An emollient formulation of clobetasol produced less
hypothalamic-pituitary-adrenal (HPA) axis suppression than the
cream formulation, and it was safe and effective for use over a 4week period in the treatment of psoriasis. This 2-phase safety and
efficacy study compared clobetasol 0.05% emollient with 0.05%
cream (1.5 g) in 12 patients with psoriasis or eczema during the
safety phase. Only 1 patient in the emollient treatment group
developed serum cortisol levels less than 10 mcg/100 mL, versus 4
in the cream treatment group. In the efficacy phase, 89 patients with
moderate to severe plaque-type psoriasis (untreated for at least 2
weeks prior to study) received either clobetasol emollient (n=44) or
emollient vehicle (n=45) on a double-blind, randomized, parallelgroup basis. Study treatments were applied 30 minutes after bathing
to lesions anywhere on the body other than the face, scalp, axillae,
groin, or rectal area. Treatment was continued twice daily for 4
weeks, not to exceed 50 g/wk. The emollient treatment group had
significantly greater symptom and severity score improvement than
the vehicle group and only mild to moderate local adverse events.
The emollient formulation of clobetasol may be clinically useful in
dermatoses requiring more that a 2-week therapy duration
[38]
.
2) Lotion
a) Hyperproliferation-related keratin (K6) cell production in psoriasis
was suppressed by the application of clobetasol-17-propionate
lotion under hydrocolloid occlusive dressing, in an open-label,
prospective study. Seven patients with clinically stable psoriasis
received hydrocolloid-occlusive treatment of moderately severe
psoriatic plaques (minimum SUM score of 6 from the Psoriasis Area
and Severity Index) with clobetasol lotion (concentration
unspecified). Each target lesion was treated weekly for up to 6
weeks or until clearance. Lesion biopsies and flow cytometry were
performed before treatment, after clearance, and at apparent
relapse. All patients achieved clearance within 6 weeks.
Postclearance biopsy demonstrated a significant reduction in
proportion of proliferative K6-positive keratin cells (p less than 0.05),
while the proportion of K10-positive cells returned to within normal
range (p less than 0.01). Subsequent follow-up confirmed the
recurrence of plaque formation; however, the associated SUM
severity scores revealed only one-half the severity (SUM=3) of
pretreatment lesions, leading the authors to propose the
phenomenon of rebound versus relapse after the withdrawal of
potent corticosteroid treatment. Such a rebound phenomenon would
support the establishment of a maintenance therapy regimen to
maintain the suppression of keratin cell hyperproliferation
[36]
.
3) Ointment
a) A combination of 2 weeks of clobetasol propionate to promote
rapid healing, followed by 4 weeks of a nonsteroidal antipsoriatic
treatment for maintenance, has been shown to restore barrier
function of the skin in severe plaque psoriasis . In this randomized,
double-blind comparison, patients applied clobetasol propionate
(0.05%) ointment to one side of the body for 2 weeks and then
calcipotriol (50 mcg/g) ointment for 4 weeks; on the other side of the
body, patients applied calcipotriol (50 mcg/g) ointment alone for 6
weeks. At the end of active treatment, lesions that had received the
combination had significantly lower overall severity scores than
lesions receiving the vitamin D(3) analogue calcipotriol only
(p=0.0002). No rebound effect occurred after termination of
treatment, although lesions gradually recurred after either treatment
[37]
.
b) Clobetasol propionate 0.05% ointment applied twice daily for 2
weeks (less than 50 g/wk) promoted a reduction in symptoms of
psoriasis and a progressive reduction in affected body surface area
in 74 patients receiving up to 3 courses of treatment. A minimum
interval of 1 week was required between courses. Nine patients
(12%) had at least 1 abnormally low morning plasma cortisol level
during therapy, and there was a strong correlation between percent
body surface area treated and abnormal plasma cortisol levels
[8]
.
c) In two small studies, clobetasol did not demonstrate therapeutic
advantage over placebo in the treatment of psoriasis. Ninety
patients were randomized to clobetasol, clobetasol with ultraviolet B
(UVB) light, or placebo and UVB. There were 21 dropouts in this
study. Among the remaining patients, combination clobetasol/UVB
did not cause a significant decrease in healing time when compared
with placebo/UVB, and single-agent clobetasol was less effective
than either of the other treatment groups
[15]
. There was no statistical difference in efficacy between clobetasol
0.05% ointment applied for 2 weeks and clobetasol applied once
daily for one week followed by placebo for one week in 12 psoriatic
patients
[14]
.
4) Spray
a) Moderate or severe psoriasis improved with clobetasol topical
spray 0.05% compared with vehicle control in 2 randomized trials.
Patients with moderate or severe/very severe plaque psoriasis
received either topical clobetasol propionate 0.05% spray or vehicle
spray for 4 weeks. Based on Overall Disease Severity (5-point scale
based on scaling, erythema, and plaque elevation), clobetasol was
superior to the vehicle control:
[32]
.
STUDY 1
DURATION SEVERITY clobetasol
(n=60)
Clear
1 (2%)
Week 2
Almost
32 (53%)
clear
vehicle
(n=60)
0 (0%)
STUDY 2
clobetasol
(n=60)
0 (0%)
vehicle
(n=60)
0 (0%)
1 (2%)
28 (47%)
0 (0%)
Week 4
Clear
Almost
clear
15 (25%)
0 (0%)
18 (30%)
0 (0%)
32 (53%)
2 (3%)
31 (52%)
1 (2%)
Scalp psoriasis (Moderate to Severe)
FDA Labeled Indication
a) Overview
FDA Approval: Adult, yes (foam, scalp solution, shampoo);
Pediatric, yes (age 12 years or older (scalp solution, Olux(R) foam))
Efficacy: Adult, Evidence favors efficacy
Recommendation: Adult, Class IIb
Strength of Evidence: Adult, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Clobetasol propionate shampoo is indicated for the treatment of
moderate to severe forms of scalp psoriasis in patients 18 years of
age and older
[44]
c) Adult:
1) Safety and efficacy of clobetasol shampoo was demonstrated in 2
separate clinical trials involving a total of 290 patients with moderate
to severe scalp psoriasis . In both trials, patients were treated with
clobetasol propionate shampoo 0.05% or a corresponding vehicle
once daily for 15 minutes over a period of 4 weeks. Success rates,
defined as the proportion of patients with a 0 (clear) or 1 (minimal)
on a 0 to 5 point physician's Global Severity Scale for scalp
psoriasis, were 42% and 28% in the groups using clobetasol
compared to 2% and 10% in the groups using shampoo vehicle.
The percentage of patients with 0 (clear) on a 0 to 3-point scalp
psoriasis parameter scale for parameters of erythema, scaling, and
plaque thickening at the end of both studies were:
PARAMETER
Erythema
Scaling
Plaque Thickening
CLOBETASOL SHAMPOO
18% and 12%
22% and 15%
37% and 34%
PLACEBO
6% and 2%
0% and 4%
11% and 10%
The study did not have a sufficient number of non-Caucasian
patients to determine whether they respond differently than
Caucasian patients with regard to safety and efficacy
[44]
.
Tight foreskin
a) Overview
FDA Approval: Adult, no; Pediatric, no
Efficacy: Pediatric, Evidence is inconclusive
Recommendation: Pediatric, Class IIb
Strength of Evidence: Pediatric, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Unretractable foreskin (phimosis) was successfully treated in 9 of 15
pediatric patients using topical clobetasol 0.5% once daily for 4
weeks, with frequent manual retraction after the first week of
therapy
[30]
.
Clobetasol cream was successful in 38 of 54 boys (ages 2 to 15
years) with phimosis. Up to 90% of surgically treated cases of
phimosis have been caused by lichen sclerosus, a condition that
has been treated with clobetasol propionate cream
[31]
.
c) Pediatric:
1) Unretractable foreskin (phimosis) was successfully treated in 9 of
15 pediatric patients using topical clobetasol 0.5% once daily for 4
weeks with frequent manual retraction after the first week of
therapy. One patient required 2 months of clobetasol treatment
before phimosis disappeared. Another patient's phimosis resolved
only after a total of 14 weeks, but this patient's therapy compliance
was questionable. Among 15 placebo-treated patients, 5 had
resolution of phimosis; 7 were crossed over to clobetasol for 6
weeks with complete resolution. Overall, clobetasol ointment was
effective in 18 of the 20 patients (90%) who used it for a median of 6
weeks during active or crossover phases of the trial
[30]
.
2) Clobetasol cream was successful in 38 of 54 boys (ages 2 to 15
years) with phimosis. Up to 90% of surgically treated cases of
phimosis have been caused by lichen sclerosus, a condition that
has been treated with clobetasol propionate cream. Clobetasol was
applied once daily to the outside of the prepuce for a mean of 49
days. No skin atrophy or other side effects were reported. Patients
not cured after 3 months of treatment were referred to surgery
[31]
.
Urticaria pigmentosa
a) Overview
FDA Approval: Adult, no; Pediatric, no
Efficacy: Adult, Evidence is inconclusive
Recommendation: Adult, Class IIb
Strength of Evidence: Adult, Category C
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Clobetasol propionate was successful in one case report of adultonset urticaria pigmentosa
[40]
.
c) Adult:
1) Adult-onset urticaria pigmentosa cleared following application of
clobetasol propionate 0.05% daily for 4 weeks . The patient
previously had an excellent response to psoralen plus ultraviolet A,
but the eruption recurred immediately after stopping therapy. The
patient maintained remission by using a single once-monthly
application of clobetasol ointment
[40]
.
Vesicular stomatitis
a) Overview
FDA Approval: Adult, no; Pediatric, no
Efficacy: Adult, Evidence favors efficacy
Recommendation: Adult, Class IIb
Strength of Evidence: Adult, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Clobetasol propionate mouthwash (0.05%) was an effective
treatment for severe, erosive lesions of the oral mucosa in an
uncontrolled study (n=30)
[26]
.
Clobetasol propionate was comparable to fluocinonide in an
adhesive paste in a double-blind study of 60 patients with lichen
planus, pemphigus, or erythema multiforme
[27]
.
c) Adult:
1) Clobetasol propionate mouthwash (0.05%) was an effective
treatment for severe, erosive lesions of the oral mucosa. In an
uncontrolled study, 30 patients were given 10 mL of an aqueous
solution containing 0.05% clobetasol propionate and nystatin
100,000 international units/mL, which they were to swish in their
mouth for 5 minutes and not swallow. Treatments were 3 times daily
for 48 weeks. Pain ulceration disappeared in 93% of cases, with
90% reporting resumption of daily activities. Two patients had no
response to therapy and 5 patients suffered adverse effects (moon
face and hirsutism), which responded to a reduction in the
frequency of mouthwash
[26]
.
2) Clobetasol was similar in efficacy to fluocinonide mixed with an
adhesive paste (Orabase(R)) in relieving the symptoms and ulcers
associated with oral vesiculoerosive disease (OVED) in a doubleblind study comprising 60 patients with lichen planus, pemphigus, or
erythema multiforme. Although not statistically significant,
clobetasol-treated patients had earlier improvement in symptoms
and pain than those treated with fluocinonide. There were no
significant differences between treatments for development of
hypothalamic-pituitary-adrenal axis suppression or clinical
candidiasis
[27]
.
3) Twenty-two of 24 patients with chronic oral vesiculoerosive
disease (OVED) responded to treatment with clobetasol propionate
0.05% ointment in an adhesive paste (Orabase(R)), applied to
lesions 2 to 3 times daily for 2 to 4 weeks. Fifteen patients had
complete remission and 7 had excellent or good responses.
Responding patients remained disease-free with continued use of
clobetasol for up to 6 months
[28]
.
Vitiligo
a) Overview
FDA Approval: Adult, no; Pediatric, no
Efficacy: Adult, Evidence is inconclusive
Recommendation: Adult, Class IIb
Strength of Evidence: Adult, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Clobetasol has been used in this condition, but side effects limit
applicability
Repigmentation varied from 15% to 90%
c) Adult:
1) Over a period of 8 months or less, 88% of 25 patients with vitiligo
had at least 90% repigmentation after treatment with clobetasol
cream (applied twice daily; maximum 12 g every 2 weeks) .
However, side effects were frequent (acne, skin atrophy,
telangiectasia, fungal infections)
[41]
.
2) Successful repigmentation was achieved in more than 80% of
patients treated with clobetasol 0.05% in 50% isopropanol for vitiligo
of the trunk and limbs, and in more than 40% of patients receiving
clobetasol as an ointment to the face and eyelids. Patients (n=75)
used the medication twice daily for 2 months on the face and 4
months elsewhere
[42]
.
3) Segmental vitiligo, an entity with a unilateral distribution distinct
from that of the nonsegmental variety, showed promising results of
topical treatment with clobetasol propionate 0.05% cream in a small
study . Out of 38 evaluated patients, 13 (34.2%) evidenced more
than 50% repigmentation of vitiliginous areas, with best results seen
in facial areas. Time before treatment was a significant factor in
response, with repigmentation occurring in significantly more
patients treated within 12 months of onset than in patients treated
more than 1 year after symptoms began (p less than 0.05). The
cream was applied to vitiliginous areas twice daily in patients with a
definite diagnosis of segmental vitiligo and disease durations
ranging from 1 month to 12 years. Unless severe side effects
required otherwise, every 6 weeks of therapy was followed by 2
weeks of rest, and responding patients received 3 courses. Side
effects required longer treatment interruptions of up to 4 weeks in 10
patients; 6 patients had mild atrophy, 4 telangiectasia, and 8
acneiform papules (Khalid & Mujtaba, 1998).
Comparative Efficacy / Evaluation With Other Therapies
Amcinonide
1) Efficacy
a) The following groups of topical corticosteroids indicate comparative
potencies
[101]
:
Relative Potencies of Commonly Used Topical Corticosteroids (Group 1, Most Potent;
Group 6, Least Potent)
1.
Clobetasol propionate 0.05%
2.
Amcinonide 0.1%
Betamethasone dipropionate 0.05%
Desoximetasone 0.25%
Diflorasone diacetate 0.05%
Fluocinonide 0.05%
Halcinonide 0.1%
3.
Betamethasone valerate 0.1%
Fluocinolone acetonide 0.025%
Flurandrenolide 0.05%
Triamcinolone acetonide 0.5%
4.
Fluocinolone acetonide 0.025%
Hydrocortisone valerate 0.2%
Triamcinolone acetonide 0.1%
5.
Desonide 0.05%
Flumethasone pivalate 0.03%
Hydrocortisone 1% (with urea)
6.
Dexamethasone 0.1%
Hydrocortisone 1% (alcohol or acetate)
Anthralin
Plaque psoriasis
a) A small, open trial in 10 in-patients with plaque psoriasis
compared the efficacy of clobetasol 0.05% ointment with anthralin
0.25% in zinc and salicylic acid paste (Lassar's paste), applied twice
daily to the right and left side of the body, respectively. Plaque
clearing occurred between 10 and 21 days. Length of remission was
significantly longer with clobetasol therapy versus anthralin (p less
than 0.005). Both therapies resulted in satisfactory plaque clearance
over a comparable time frame. Clobetasol had the added benefit of
not causing the skin irritation and staining associated with anthralin
[128]
.
b) An open, randomized trial compared the effects of anthralin and
UVB irradiation (Ingram regimen) with and without the addition of
clobetasol ointment in 50 out-patients with plaque psoriasis. After
treatment with UVB irradiation, all patients received anthralin 0.05%
to 2% daily for 4 hours until plaques cleared, then twice weekly for 4
weeks. Twenty-six patients also received a tapering regimen of
clobetasol for 4 weeks. The median time for plaque clearance was
2.5 weeks with anthralin and clobetasol therapy, versus 4 weeks
with anthralin alone (p less than 0.05). Overall response rates and
adverse events were comparable between treatment groups.
Although relapse tended to occur more frequently in the clobetasoltreated patients, the rate between the two treatment groups was not
significant
[129]
.
Betamethasone
Psoriasis
a) Summary: In most studies, clobetasol was more effective than
betamethasone in the treatment of psoriasis vulgaris. It appears that
the base (cream, ointment, or alcoholic solution) affects absorption
as well as efficacy.
b) Clobetasol propionate was shown to be more effective than
betamethasone valerate, a mid-potency corticosteroid cream
[121]
, ointment (Corbett, 1976), and lotion
[122]
formulations when compared in controlled studies with like
formulations.
c) Alcoholic solutions of clobetasol and betamethasone dipropionate
were compared in patients with scalp psoriasis. Both treatment
groups showed a decrease in scaling and itching of lesions.
Complete induration of lesions occurred in 80% of the patients
receiving clobetasol compared with 55% in the betamethasone
group
[123]
.
d) In a series of studies, clobetasol propionate ointment was
compared to betamethasone dipropionate in an optimized ointment
(super high potency)
[124]
[125]
. Both treatments were equi-effective but in another trial significantly
more crobetasol propionate patients had a better response than the
betamethasone group
[126]
.
Calcipotriene
Psoriasis
a) Calcipotriene (CPT) ointment twice daily in combination with
tazarotene (TZT) gel once daily was as effective as clobetasol
(CBS) ointment used twice daily in the treatment of plaque
psoriasis. In a prospective, open-label, right/left comparison, pilot
study, patients (n=15) with at least 1 "mirror-image" pair of
symmetric lesions of plaque psoriasis and an established diagnosis
of psoriasis vulgaris, which was clinically stable for the previous
month, received therapy for two weeks, then underwent observation
during a 4-week post-treatment period. Following a washout phase,
28 target lesion pairs were randomly assigned to treatment in which
one lesion received two weeks of therapy with CPT ointment and
TZT gel each morning plus CPT ointment in the evening and the
matched lesion received CBS ointment twice daily for two weeks.
Erythema, scaling, plaque elevation and overall lesional severity
were assessed at 0, 2, 4, and 6 weeks. At 2 weeks, lesions treated
with CPT plus tazarotene showed almost equal reductions in
scaling, plaque elevation, and overall lesional severity as compared
with the CBS-treated lesions. During the 2-week treatment phase,
erythema was significantly more improved in lesions treated with
clobetasol (p less than 0.01) than with the combination therapy.
During the observation phase, plaque elevation reappeared more
quickly in the CPT-plus-TZT-treated lesions (p less than 0.01) than
in the CBS- treated lesions. However, no difference was seen in
changes in scaling, erythema, and overall lesional severity between
the two therapies. Both treatments were well tolerated. No adverse
events were reported in the CBS group. Adverse events in the CPTplus-TZT group were mild, including asymptomatic erythema and
peeling
[127]
.
Cyclosporine
Psoriasis
a) The addition of clobetasol to cyclosporine A cleared psoriasis
faster than cyclosporine A alone but did not slow the relapse rate
[118]
.
Diflorasone
Psoriasis
a) Diflorasone diacetate 0.05% in a potency-enhancing ointment
vehicle (Psorcon(R)) was compared to clobetasol propionate 0.05%
ointment in 60 patients with moderate to severe psoriasis using a
bilateral, paired-comparison double-blind design
[130]
. Patients were treated twice a day for two weeks. There was a two
week follow-up period. Results indicate a more rapid clearing with
clobetasol propionate. Clobetasol was significantly more effective in
reducing erythema, scaling and skin thickening at the one-week,
two-week and follow-up evaluations. The clobetasol treated lesions
displayed clearing in 21% of the patients at the two-week
evaluation, compared to 9% with diflorasone diacetate (p less than
0.05).
Diflucortolone
Eczema
a) Two studies comparing the topical effectiveness of clobetasol
propionate 0.05% and diflucortolone valerate 0.3% cream reported
comparable effectiveness with no significant differences between
them. Incidence and severity of side effects were also similar
[119]
[120]
.
Fluocinolone
Psoriasis
a) In a multi-comparative study involving 1150 patients with
psoriasis or eczema, clobetasol 0.05% for seven days was found to
be more effective in improving the conditions than betamethasone,
fluocinolone, or fluclorolone
[110]
.
b) In a double-blind comparison study of twice-daily 0.05%
clobetasol ointment versus 0.025% fluocinolane acetonide ointment,
it was found that resolution lasted longer and relapses were less
severe on the sides treated with clobetasol ointment
[111]
.
Fluocinonide
Disorder of oral soft tissues
a) Clobetasol propionate 0.05% and fluocinonide 0.05% mixed in
Orabase produced similar decreases in erythema, atrophy, and
ulcer size in patients with oral vesiculoerosive disease
[112]
. Seventy-five percent of the observations in each group showed
improvement. There were not significant differences between
treatments; however, pain control was better in the clobetasol group
during the first and second weeks. This study included 60 patients
with lichen planus (n=35), benign pemphigoid (n=3), pemphigus
vulgaris (n=3), and erythema multiforme (n=19). This was a
randomized, double-blind clinical trial which lasted 28 days (eg, 2
weeks on treatment, 2 weeks off treatment).
Psoriasis
a) SUMMARY: Clobetasol appears to be superior to fluocinonide in
the treatment of psoriasis and eczema. Clobetasol should be used
only for short courses (2 weeks maximum) and assessment of
hypothalamic-pituitary-adrenal axis (HPA) function is required if
longer therapy is administered
[113]
.
b) Clobetasol propionate cream (0.05%) was significantly more
effective than fluocinonide cream (0.05%), each applied three times
daily for 2 weeks, in the treatment of moderate-to-severe psoriasis
and eczema in a multicenter double-blind study involving 227
patients
[114]
. Clobetasol was associated with greater resolution of signs and
symptoms and more rapid healing of lesions; fewer relapses
occurred after clobetasol therapy. Fluocinonide was associated with
a greater incidence of side effects (12% versus 4%). Morning
cortisol levels were below 5 mcg/dL in 6% of clobetasol-treated
patients compared to one fluocinonide-treated patient after 2 weeks
of treatment. This suggests a greater propensity of clobetasol to
induce adrenal suppression.
c) Clobetasol propionate ointment 0.05% applied once daily was
superior to fluocinonide 0.05% ointment applied three times daily in
the treatment of moderate-to-severe psoriasis in a 2-week singleblind study involving 125 patients
[115]
. At the end of two weeks of treatment, marked improvement or
clearing of lesions was observed in 61% of clobetasol-treated
patients and in 38% of fluocinonide-treated patients. At seven days
post-treatment (day 22), marked improvement or clearing of lesions
was observed in 42% and 23% of clobetasol- and fluocinonidetreated patients, respectively. While the morning plasma cortisol
levels dropped below 5 mcg% in two patients (3%) receiving
clobetasol, levels returned to normal within one week following
therapy.
Halcinonide
Psoriasis
a) Although one early study found no statistically significant
difference between paired psoriatic lesions treated with either the
class II 0.1% halcinonide cream or clobetasol cream
[105]
, a more recent study employing a larger patient population found
clobetasol to be superior
[106]
. In this later double-blind comparison study of 70 patients with
psoriasis, 42.9% of the clobetasol-treated sides had greater than
75% clearing versus only 15.8% of the halcinonide-treated sides. Of
sixty-two follow-up patients examined two weeks after treatment,
62.9% relapsed first on the halcinonide-treated side versus 3.2% on
the clobetasol-treated side.
Halobetasol
Atopic dermatitis
a) Halobetasol ointment or clobetasol was given 127 patients with
chronic, localized atopic dermatitis or lichen simplex chronicus in a
multicenter, parallel-group comparative trial
[108]
. The success rates of healed or marked improvement were similar
for the treatments (93.7 vs 92.2%, respectively). Healing was
reported in a higher proportion of patients treated with halobetasol
(65.1% and 54.7%). Both preparations were well tolerated.
b) In a double-blind, parallel-group study, halobetasol and
clobetasol cream were compared in patients with acute, severe
exacerbations of atopic dermatitis
[109]
. All patients had satisfactory and similar results.
Psoriasis
a) A double-blind, parallel-group study comparing 0.05%
halobetasol ointment and 0.05% clobetasol ointment was reported
in 134 patients with psoriasis
[107]
. A significantly larger proportion of patients treated with halobetasol
had no or mild disease after 14 days compared with those treated
with clobetasol (86% vs 70%). Adverse events were reported in a
smaller percentage of patients treated with halobetasol (7% vs 12%,
respectively).
Hydrocortisone
Eczema
a) Clobetasol was of comparable efficacy to hydrocortisone in 40
patients with symmetrical eczematous lesions. A double-blind trial
was conducted using clobetasol 0.05% and hydrocortisone 0.1% in
cream bases. Seven cases showed a favorable response to
clobetasol and nine cases to hydrocortisone. In 24 cases both sides
responded equally. Complete healing after two weeks' treatment
occurred in eight cases with clobetasol and 10 hydrocortisonetreated cases
[116]
.
Psoriasis
a) Five different corticosteroid lotions occluded under a hydrocolloid
dressing (Actiderm) for one week in patients with psoriasis (n=23),
eczema (n=8), and other dermatoses (n=9) were observed
[117]
. Preparations applied included clobetasol propionate 0.05%,
betamethasone valerate hydrocortisone 1% dissolved in 99%
alcohol, and an alcohol control. Medication was re-applied under the
hydrocolloid dressing for a second week. Areas treated with
clobetasol, betamethasone, and triamcinolone were clinically healed
in four patients in one week, with residual redness in four others.
Patients treated only with betamethasone valerate under
hydrocolloid dressing once a week for three weeks also had healed
lesions for various dermatoses. Results showed no advantage of
using the more potent corticosteroid, clobetasol, under the
hydrocolloid dressing. Hydrocortisone did not induce healing as well
as did other corticosteroids.
Adverse Effects
a) A long-term double-blind study attempted to assess side effects in 10
volunteers who received six different ointments (hydrocortisone 1%/urea
10%, hydrocortisone butyrate 0.1%, clobetasol propionate 0.05%,
clobetasol butyrate 0.05%, urea 10%, and white soft paraffin) applied to six
different sites on the forearm (Dykes & Markes, 1977). Over the eight
weeks of therapy, all sites showed some atrophy. Only clobetasol
propionate showed a statistically significant difference between initial and
final skin thickness.
Pimecrolimus
Psoriasis
a) In one small randomized comparison with topical clobetasol
(nonblinded), pimecrolimus 1% ointment applied once daily for 2
weeks under Finn chamber occlusion significantly reduced clinical
scores compared to placebo (82% versus 18%). With clobetasol
0.05% ointment under occlusion, efficacy was statistically similar
(92% decrease in scores)
[104]
.
Tazarotene
Psoriasis
a) Calcipotriene (CPT) ointment twice daily in combination with
tazarotene (TZT) gel once daily was as effective as clobetasol
(CBS) ointment used twice daily in the treatment of plaque
psoriasis. In a prospective, open-label, right/left comparison, pilot
study, patients (n=15) with at least 1 "mirror-image" pair of
symmetric lesions of plaque psoriasis and an established diagnosis
of psoriasis vulgaris, which was clinically stable for the previous
month, received therapy for two weeks, then underwent observation
during a 4-week post-treatment period. Following a washout phase,
28 target lesion pairs were randomly assigned to treatment in which
one lesion received two weeks of therapy with CPT ointment and
TZT gel each morning plus CPT ointment in the evening and the
matched lesion received CBS ointment twice daily for two weeks.
Erythema, scaling, plaque elevation and overall lesional severity
were assessed at 0, 2, 4, and 6 weeks. At 2 weeks, lesions treated
with CPT plus tazarotene showed almost equal reductions in
scaling, plaque elevation, and overall lesional severity as compared
with the CBS-treated lesions. During the 2-week treatment phase,
erythema was significantly more improved in lesions treated with
clobetasol (p less than 0.01) than with the combination therapy.
During the observation phase, plaque elevation reappeared more
quickly in the CPT-plus-TZT-treated lesions (p less than 0.01) than
in the CBS- treated lesions. However, no difference was seen in
changes in scaling, erythema, and overall lesional severity between
the two therapies. Both treatments were well tolerated. No adverse
events were reported in the CBS group. Adverse events in the CPTplus-TZT group were mild, including asymptomatic erythema and
peeling
[103]
.
REFERENCES
1. Product Information: TEMOVATE(R) E topical cream, clobetasol propionate 0.05%
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