Download Natural Calcitriol Ointment in the treatment of Mild

Safety and efficacy study data
Cestrum diurnum extract Ointment containing
Natural Calcitriol
in the treatment of
Mild to Moderate Plaque Psoriasis
DR.G. Raghurama Rao, M.D
Professor & HOD of DVL,
GSL Medical College, Rajahmundry.
Consultant Dermatologist, Surya Skin Care and Research Centre, Visakhapatnam.
Background
•
First time in the world, natural calcitriol from
plant source (Solanacea) is being commercially
produced by the pioneering work of Genova
Biotech, Hyderabad.
•
Calcitriol is a D3 analogue known to be the
most effective non-steroidal alternative in the
treatment of mild to moderate plaque psoriasis.
•
This is also the preferred drug of choice in
treating sensitive areas such as scalp, post
auricular area and flexures.
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Study Design
•
Single centre, non randomized, open label Phase III Study
•
Objective: To study the efficacy, safety, and patient compliance of
topical Cestrum diurnum extract 1%w/w)
•
ointment containing natural calcitriol, 0.0003% (3mcg/gm) in the
treatment of mild to moderate plaque psoriasis
•
Study Period: 01-Feb-2010 to 30-Jun-2010
•
Total no. of subjects inducted into study - 53
•
A total of 46 patients with a mean age of 41.6 yrs completed study
specific procedures.
a) 28 patients with psoriasis involving arms/trunk/legs
b) 18 patients with scalp psoriasis
•
Dropouts - 7
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Inclusion Criteria
•
Male and female patients aged 18 years or above
•
Psoriasis vulgaris involving arms / trunk / legs / scalp
•
Patients were enrolled after informed consent
•
Women of childbearing ability to undergo urine pregnancy testing
•
Subjects who completed medical screening
•
Subjects who could be available for all study related visits
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Exclusion Criteria
•
Patients with acute guttate, generalized pustular or erythrodermic
exfoliative psoriasis, atopic dermatitis, seborrhoeic dermatitis or
other inflammatory skin diseases
•
Systemic antipsoriatic treatment or phototherapy within the last 6
weeks
•
Patients who used any topical antipsoriatic treatment on the body
within the previous 2 weeks, except emollients.
•
Usage of corticosteroids for any reason within the last 6 weeks of
the start of the Study
•
Patients with planned changes in the concomitant medications (e.g.
beta blockers, lithium etc.) that affect their psoriasis during the study
period
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Exclusion Criteria – Cont.
•
Women who are breast feeding, pregnant or wish to become
pregnant during study
•
Subjects with eye infections
•
Who had received treatment with an investigational drug within last
3 months and who are currently participating in any of the clinical
trial
•
Subjects with uncontrolled metabolic diseases such as
diabetes/hypertension, hyper or hypothyroidism
•
Subjects with abnormal liver / renal function tests and known
hypercalcinosis
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Method
•
At baseline, informed consent was obtained after checking the inclusion and
exclusion criteria and relevant medical history
•
All prior medications were stopped 2 weeks before the start of the study
•
Only application of an emollient (coconut oil) was permitted
•
Total lesion severity scores (TLSS) and global assessment scoring system were
administered throughout the study
•
Patients were enquired about adverse events and compliance with the study
medication on all follow ups
•
The patients were asked to apply the ointment twice daily
•
No concomitant drugs were allowed during the study
•
Photographic evaluation was also done
•
Statistical methods were employed to study the significance level from baseline to
follow up
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TLSS and Global Assessment
• Changes in the mean TLSS and global assessment
were compared from baseline to follow up
• There was extremely significant decrease in the scores
1. Erythema
(p=<0.0001)
2. Infiltration
(p=<0.0001)
3. Scaling
(p=<0.0001)
• One patient reported mild irritation
• No other adverse effects were observed during the
follow up period of 4 months
• No relapses were observed, up to 4 months after study
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Total Lesion Severity Score
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Results
•
54% cases, total clearance was observed after 8 weeks
•
22% cases total clearance after 12 weeks
•
9% cases total clearance after 16 weeks
•
2% cases total clearance after 20 weeks
•
13% cases poor or no response
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Baseline Global Assessment Score
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Change in Global Assessment – After 12 weeks
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Change from Baseline – After 12 weeks
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Change in Global Assessment – After 20 weeks
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Change from Baseline – After 20 weeks
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Clinical Photographs
BEFORE
AFTER
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Clinical Photographs
BEFORE
AFTER
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Clinical Photographs
Before
After
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Clinical Photographs
Before
After
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Clinical Photographs
Before
After
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Clinical Photographs
Before
After
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Clinical Photographs
Before
After
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Clinical Photographs
Before
After
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Clinical Photographs
Before
After
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Comment
Cestrum diurnum extract 1% w/w ointment
containing(Natural Calcitriol) is a safe and
effective treatment and alternative to topical
steroids in the treatment of mild to moderate
plaque psoriasis of body and scalp
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Thank You!