Download An Open Clinical Study to Evaluate Safety and Efficacy of Hairzone

Original article
An Open Clinical Study to Evaluate Safety and Efficacy of
Hairzone® Solution in the Management of Diffuse Hair Loss
Uma Agarwal*, Deepa HS**, Suprabha Hegde**
Abstract
Diffuse hair loss can affect both sexes at any age. The present clinical study was conducted to evaluate the safety and efficacy
of Hairzone® solution in 28 patients with diffuse hair loss. All the patients were instructed to gently massage the solution on
to the entire area of the scalp, leave it overnight and rinse it in the morning. Response to the therapy was evaluated at the
end of six weeks. Changes in various parameters from baseline values to the values at the end of six weeks were evaluated
by Fisher exact test. Criteria for evaluation included parameters such as moisturizing effect and reduction in hair fall and
associated symptoms such as itching and dryness of scalp. Results of the present study clearly demonstrated the beneficial
effects of Hairzone® solution in diffuse hair loss, as evidenced by decrease in hair fall, improvement in scalp condition and
relief from itching. There were no significant adverse reactions, either reported or observed, during the entire study period
and the overall compliance to the treatment was good. Therefore, it may be concluded that Hairzone® solution is clinically
effective and safe in the management of diffuse hair loss.
Key words: Hairzone® solution, diffuse hair loss, alopecia
H
intake, hair shaft abnormalities and disease conditions
such as typhoid, malaria and jaundice may cause
hair fall.3 Most cases of hair loss are due to changes in
hair cycle.
A number of factors are involved in hair disorders.
Genetic factors, diet, endocrine abnormalities, drug
The average rate of hair growth in a normal scalp is
0.35 mm a day; however, slower growth occurs in
elderly people and in patients with chronic illness.4
Scalp hair grows in an asynchronous pattern, in three
cyclic phases: Anagen (growth), catagen (involution)
and telogen (rest). Approximately 80% of the hair
follicles are present in the anagen phase, which may be
as short as 2-6 years. The remaining 10-20% of the hair
follicles are present in the catagen and telogen phases.
The catagen phase, which is between two and three
weeks, sees an increase in the growth activity of hair
follicles. The hair follicles then move on to the final
phase–telogen-which lasts for 2-3 months. In this phase,
the hair follicles move into resting state. In general,
100-150 telogen hairs are shed at random everyday.5
Most people have about 1,00,000 scalp hairs and
normally 10-15% of these are in the telogen phase.6
*Skin, Hair, Allergy Cosmetology Specialist
Skin-a-Health Centre, Hooghly, West Bengal
**Research Associate, R&D Center
The Himalaya Drug Company, Makali, Bangalore
Address for correspondence
Dr Suprabha Hegde
R&D Center
The Himalaya Drug Company
Makali, Bangalore - 562 123, Karnataka
E-mail: [email protected]
A type of hair loss, traction alopecia is commonly
found in individuals with ponytails or cornrows who
pull on their hair with excessive force. Trichotillomania,
another type of hair loss, is caused by compulsive
pulling and bending of the hairs. It tends to occur
more commonly in children than in adults. In this
condition, although not completely absent from
air loss is a common and distressing problem,
affecting men and women of all ages. It
can range from a small bare patch to a
more diffuse and obvious pattern. Diffuse hair loss,
a type of hair loss that can occur at any age, tends to
affect the whole scalp rather than specific areas of it.
Although medically benign, hair loss has been shown
to have notably deleterious effects on body image, selfesteem and psychologic well-being of an individual.1
Androgenetic alopecia or pattern baldness, the most
widespread form of hair loss, is a common disorder
affecting both men and women. It affects upto 50% of
men by the age of 50 years and upto 80% of men by the
age of 80 years. Androgenetic alopecia is also present
in a significant number of women. It is estimated that
20-40% of women suffer from this condition, although
not with the same severity as men.2 In women, hair
loss typically begins in their twenties to forties and
continues to progress with increasing age.
308
Indian Journal of Clinical Practice, Vol. 21, No. 7, December 2010
Original article
the scalp, the hair breaks easily. Trauma conditions
such as chemotherapy, childbirth, major surgery,
poisoning and severe stress may cause a type of hair
loss known as telogen effluvium. Worrisome hair loss is
often seen in women after childbirth. Alopecia areata,
also known as ‘spot baldness,’ is an autoimmune
disorder, which can result in hair loss at one location
(Alopecia areata monolocularis) to the entire body (Alopecia
areata universalis).
Iron deficiency is a common cause of hair thinning,
though frank baldness is not usually seen. Radiation
to the scalp, in radiotherapy for the treatment of
certain cancers, may cause baldness of the irradiated
areas. Hypothyroidism can cause hair loss, typically
frontal and is particularly associated with thinning
of the outer third of the eyebrows. Hyperthyroidism
can also cause hair loss, which is parietal rather than
frontal. Temporary loss of hair can occur in areas where
sebaceous cysts are present for considerable duration;
normally one to several weeks in length.
The diagnosis of hair disorders is complex, and
diagnostic techniques include clinical examination
such as scalp condition; hair loss pattern; length and
diameter of hair fibers; hair pulls; one-minute combing
test; clipping, plucking and microscopic examination
of hair fibers; scrapings of scalp scales for microbial
culture and scalp-punch biopsy. Other laboratory tests
such as complete blood count, ferritin measurement,
and thyroid screening may be helpful.
Several therapies are available for hair loss, and
biological response modifiers (e.g., topical minoxidil)
and selective antiandrogens are the most commonly
used treatment options. In women, in addition to the
antiandrogens, hormone replacement therapy can be
used. Use of systemic corticosteroids is controversial
because of prolonged treatment duration and potential
side effects, which include cataract, osteopenia,
osteoporosis and growth retardation.7 In the present
study, Hairzone® solution, containing the extracts of
Butea monosperma and Butea parviflora, is evaluated for
its efficacy and safety in the management of diffuse
hair loss.
Aim of the Study
The aim of this study was to evaluate the safety and
efficacy of Hairzone® solution in diffuse hair loss.
Indian Journal of Clinical Practice, Vol. 21, No. 7, December 2010
Material and Methods
The present study was an open clinical trial conducted
at Skin-a-Health Centre, Hooghly, West Bengal, India.
The study protocol, case report forms, regulatory
documents, product information and informed
consent forms were submitted to the ‘Institutional
Ethics Committee’ and were approved by the same.
Individuals who were aged 18 years and above with
diffuse hair loss and who were willing to give a written
informed consent were enrolled in the study. Individuals
on immunosuppressive drugs, with evidence of skin
infection and who had used any other topical therapy
for diffuse hair loss in the two weeks prior to the
initiation of the study were excluded. Pregnant and
lactating women and those who were not willing to
give the written informed consent were also excluded
from the study.
Study Procedure
A total of 28 patients (13 men and 15 women),
with a mean age of 28.18 ± 10.45 years, were
included in the study and their demographic medical
histories (including local fungal infection, dandruff,
pediculosis, trichotillomania, stress, diet, past illness
and drugs) and treatment details were recorded.
The mean duration of hair loss in these patients was
15.36 ± 12.76 months ranging from three to 28 months
(Table 1). The patients underwent a thorough clinical
and scalp skin examination (which included assessment
of number of hairs lost in one-minute combing test and
presence of alopecia patches). At entry, 15 patients
presented with dandruff, one with pediculosis and
18 with itching; 10 patients presented with jaundice
(Table 2). All the patients were advised to gently
massage the solution on to the entire area of the scalp,
leave it overnight, and rinse it in the morning. Response
to the therapy was evaluated at entry and at the end of
six weeks. Criteria for evaluation included parameters
such as moisturizing effect and reduction in hair fall
Table 1. Demographic Data of Patients on
Entry (n = 28)
Parameter
Age in years (mean ± SD)
Sex ratio (M:F)
Diet (veg:mixed)
Duration of illness (months)
Hairzone® solution
28.18 ± 10.45
13:15
20:08
15.36 ± 12.76
309
Original article
Results
Table 2. Precipitating Factors
Local factors
Factor
Number of patients
Dandruff
15
Pediculosis
1
Itching
18
Jaundice
10
Systemic factor
(observed by one-minute comb test) and associated
symptoms such as itching and dryness of scalp.
All the adverse events, either reported or observed by
the patients, were recorded with information about
severity, date of onset, duration and action taken
regarding the study drug. Relation of adverse events to
study medication was predefined as ‘Unrelated’ (does
not follow a reasonable temporal sequence from the
administration of the drug), ‘Possible’ (follows a known
response pattern to the suspected drug, but could have
been produced by the patient’s clinical state or other
modes of therapy administered to the patient) and
‘Probable’ (follows a known response pattern to the
suspected drug that could not be reasonably explained by
the known characteristics of the patient’s clinical state).
Patients were allowed to voluntarily withdraw from the
study, if they experienced any serious discomfort during
the study or sustained serious clinical events requiring
specific treatment. For those withdrawing from the
study, efforts were made to ascertain the reason for
dropout. Noncompliance (defined as failure to take
less than 80% of the medication) was not regarded as
treatment failure, and reasons for noncompliance were
noted. All the patients completed the study as planned
and their data were available for analysis.
Primary and Secondary Endpoints
The predefined primary endpoint was presence or
absence of symptoms of diffuse hair loss, whereas the
predefined secondary endpoints were acute and chronic
safety, which were assessed by the incidence of adverse
events and patient compliance to the therapy.
310
Results of the study showed that most patients
treated with Hairzone® solution responded well to
the therapy. Mean hair fall reduced significantly from
96.25 ± 50.86 (before treatment) to 38.75 ± 32.44
(after six weeks of treatment; p < 0.0001). Itching
disappeared in all the 18 affected individuals and
moisturizing effect was appreciated by 25 patients
after six weeks of treatment, both with a significance
of p < 0.0001. An improvement in scalp condition,
which includes clinical parameters such as pediculosis,
dandruff, denuded patches and epidermal changes,
was observed in all the 28 enrolled patients after six
weeks of treatment with a significance of p < 0.0001
(Table 3 and Fig. 1). None of the patients reported
edema, erythema, pruritus or burning sensation on
first as well as on continued application of the solution.
No significant adverse effects were either reported or
observed during the entire study period and the overall
compliance to the treatment was good.
Discussion
Diffuse hair loss can affect both sexes at any age.
Triggers that interrupt the normal hair cycle, such
Table 3. Evaluation of the Effect of Hairzone® Solution
Parameters
Mean hair fall in 1-minute
comb test (mean ± SD)
At entry
6 weeks
96.25 ± 50.86
38.75 ± 32.44*
Itching (number of patients)
18
0*
Moisturizing effect (number
of patients)
-
25*
Improvement in scalp
condition (number of
patients)
-
28*
*p < 0.0001 as compared with ‘at entry’ values.
120
100
80
Statistical Analysis
60
Values are expressed as mean ± SD. Statistical analysis
was performed by Fisher exact test using GraphPad
Prism, Version 4.03 for Windows, GraphPad Software,
San Diego, California, USA; www.graphpad.com.
The changes in various parameters from baseline
values to after treatment values were evaluated by
‘paired t-test’.
40
96.25
±
50.86
*p < 0.0001 as compared to
‘at entry’ value
*
At end of 6 weeks
18
20
0
At entry
38.75
±
32.44
Mean hair
fall in 1-minute
comb test
*
0
Itching
*
25
0
Moisturizing
effect
*
28
0
Scalp
condition
Figure 1. Clinical effect of Hairzone® solution.
Indian Journal of Clinical Practice, Vol. 21, No. 7, December 2010
Original article
as physiologic or emotional stresses, nutritional
deficiencies and endocrine imbalances, may cause
diffuse hair loss. Finding the cause or trigger of
the hair loss requires knowledge of the patient’s
medical history and a thorough clinical examination.
Patient education is the key in the management
of diffuse hair loss. Management of hair fall is an
extremely complex issue. Treatments for various forms
of hair loss have limited success with unwanted adverse
effects. Hormone therapy, α-reductase inhibitors and
vasodilators like minoxidil have also been widely
used to reduce hair fall.3 Several new technologies in
cosmetic transplant surgery and hair replacement are
currently available.
Results of the present study showed that Hairzone®
solution, containing herbal extracts of B. monosperma
and B. parviflora, is effective in the management of
diffuse hair loss. Both B. monosperma and B. parviflora
inhibit hair follicular degeneration and extend the
anagen phase of the hair growth cycle; they also
enhance proliferation and maturation of precursor
epithelial cells of the final hair strand. Also, these
herbs prevent the massive apoptosis in the proximal
hair bulb and help in the multiplication of hair fiber
cells with the stimulation of anagenic phase, reducing
the catagenic and telogenic phases.8 B. monosperma
displays antifungal activity against Cladosporium
cladosporioides.9 It also has a significant bactericidal
effect,10 potent antiviral activities11 and astringent
action,12,13 which tends to shrink or constrict body
tissues locally after topical medicinal application. The
herb is also found to possess free radical scavenging
activity.14 B. parviflora possesses antimicrobial action.15
Therefore from the above findings, it can be concluded
that the clinical efficacy of Hairzone® solution in the
management of diffuse hair loss is due to the synergistic
actions of its potent herbs.
Conclusion
The present clinical study clearly demonstrated the
beneficial effects of Hairzone® solution in diffuse hair
loss as evidenced by parameters such as moisturizing
effect and decrease in hair fall and associated symptoms
such as itching and dryness of scalp. No significant
adverse effects were either reported or observed
during the entire study period and the overall compliance
to the treatment was good. Therefore, it can be
concluded that Hairzone® solution is clinically effective
and safe in the management of diffuse hair loss.
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