To Evaluate the Therapeutic Equivalence and Safety in Treatment of Scalp Psoriasis

Study Overview
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Brief Summary
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To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.

Detailed Description
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Multi-center, double-blind, randomized, placebo controlled, parallel-group study comparing test and reference products to a placebo control in the treatment of scalp psoriasis

Official Title
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Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study Comparing Taro Product to RLD and Both Active Treatments to a Placebo Control in the Treatment of Scalp Psoriasis

Conditions
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Scalp Psoriasis

Intervention / Treatment
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* Drug: Betamethasone Scalp Suspension 0.064%;0.0005%
* Drug: Taclonex®
* Drug: Placebo topical suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or non-pregnant female aged ≥18 years All male subjects had to agree to use accepted methods of birth control with their partners, from the day of the first application of the study drug to 30 days after the last application of the study drug Willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp Exclusion Criteria: Female subjects who were pregnant, nursing, or planning to become pregnant during study participation Known hypersensitivity to calcipotriene, betamethasone dipropionate, other corticosteroids, or to any ingredients in the study drugs Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Product<br>Betamethasone Scalp Suspension 0.064%;0.0005% (Taro Pharmaceuticals Inc.) | Drug: Betamethasone Scalp Suspension 0.064%;0.0005%<br>* applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.<br>* Other names: Taclonex;|
| Active Comparator: Reference Product<br>Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA) | Drug: Taclonex®<br>* applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.<br>* Other names: Calcipotriene and Betamethasone Dipropionate;|
| Placebo Comparator: Placebo<br>Vehicle of the test product (Taro Pharmaceuticals Inc.) | Drug: Placebo topical suspension<br>* applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment success on the Physician's Global Assessment (PGA) of disease severity | The proportion of subjects in each treatment group with treatment success (defined as none or minimal, a score of 0 or 1, within the treatment area) on the PGA of disease severity | Study Week 4 (Day 28 ± 4 days) | 
| clinical success on the Physician's Global Assessment (PASI) of disease severity | The proportion of subjects in each treatment group with clinical success (defined as clear or almost clear, a score of 0 or 1, at the target lesion site) on the PASI. Each psoriatic sign of scaling, erythema and plaque elevation should have a score of 0 or 1 for the subject to be considered a clinical success. The target lesion is to be identified at Baseline as the most severe lesion. | Study Week 4 (Day 28 ± 4 days) |