Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.

Official Title
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A Multi-Center, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Clobetasol Propionate Spray Versus Vehicle for the Management of Moderate to Severe Plaque Psoriasis of the Scalp

Conditions
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Scalp Psoriasis

Intervention / Treatment
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* Drug: clobetasol propionate spray 0.05%
* Drug: Vehicle spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with diagnosis of moderate to severe plaque psoriasis of the scalp Exclusion Criteria: Subjects who need systemic treatment for their body psoriasis Subjects who have surface area involvement too large (>20% Body Surface Area [BSA]) that would require more than 50 grams per week of study product

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clobex Spray<br> | Drug: clobetasol propionate spray 0.05%<br>* Apply enough product to cover affected areas topically twice daily at least 8 hours apart<br>* Other names: Clobex® Spray 0.05%;|
| Placebo Comparator: Vehicle spray<br> | Drug: Vehicle spray<br>* Apply enough product to cover affected areas topically twice daily at least 8 hours apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear) | Number of participants who were a success or failure based on the Global Severity Score (GSS) of Scalp Psoriasis from baseline to end of treatment (Week 4 or Week 2 if Clear). GSS is evaluated on a scale from 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe) with 0 being best and 5 being worst. Success is defined as Clear or Almost Clear. (Note: 5 Clobex Spray subjects and 0 Vehicle Spray subjects were Clear at week 2 and their results were carried forward to week 4). | baseline to week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst. | baseline to week 4 | 
| Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Number of participants in each category of the Extent of Scalp Involvement Index at end of treatment (week 4 or week 2 if GSS was Clear). The Extent of Scalp Involvement Index is evaluated on a scale from 0 - 5 (0 = None, 2 = <20%, 2 = 20-39%, 3 = 40-59%, 4 = 60-79% and 5 = 80-100%) with 0 being best and 5 being worst. | baseline to week 4 | 
| Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Number of participants in each category of Pruritus at end of treatment (week 4 or week 2 if GSS was Clear). Pruritus is evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate and 3 = Severe) with 0 being best and 3 being worst. | baseline to week 4 |