Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis

Study Overview
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Brief Summary
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This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.

Detailed Description
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Same as above.

Official Title
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A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate Ointment With Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: clobetasol propionate spray
* Drug: clobetasol propionate ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with a diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% of the body surface area. For the purposes of study treatment, most areas will be treated with the exception of face, scalp, groin, axillae and other intertriginous areas Overall disease severity is at least 3 (moderate) Exclusion Criteria: Subjects who have surface area involvement too large that would require more than 50 grams per week of clobetasol propionate spray or more than 50 grams per week of clobetasol propionate ointment Subjects whose psoriasis involves only the scalp, face or groin Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: clobetasol propionate spray<br>clobetasol propionate spray 0.05% | Drug: clobetasol propionate spray<br>* Apply twice daily<br>* Other names: Clobex® Spray;|
| Active Comparator: clobetasol propionate ointment<br>clobetasol propionate ointment 0.05% | Drug: clobetasol propionate ointment<br>* Apply twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale | Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe with Clear/Almost Clear being best and Severe/Very Severe being worst) from Baseline to End of Treatment (wk 4 - clobetasol propionate spray; wk 2 - clobetasol propionate ointment) | Baseline and Week 2 and Baseline and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to After Two Weeks of Treatment Based on the Overall Disease Severity (ODS) Scale | Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst from Baseline to after 2 weeks of treatment | Baseline and Week 2 | 
| Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to 2 Weeks Post Treatment Based on the Overall Disease Severity (ODS) Scale | Success Rate on Overall Disease Severity scale (Clear/Almost Clear, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst at 2 weeks post treatment (week 6 - clobetasol propionate spray and week 4 - clobetasol propionate ointment) | Baseline and Week 4 and Baseline and Week 6 | 
| Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment | Success Rate of decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment | Baseline and Week 2 | 
| Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment | Success Rate of decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment | Baseline and Week 2 | 
| Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment | Success Rate of decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment | Baseline and Week 2 | 
| Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment | Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment) | Baseline and Week 2 and Baseline and Week 4 | 
| Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment | Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment) | Baseline and Week 2 and Baseline and Week 4 | 
| Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment | Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment) | Baseline and Week 2 and Baseline and Week 4 | 
| Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment | Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment) | Baseline and Week 4 and Baseline and Week 6 | 
| Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment | Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment) | Baseline and Week 4 and Baseline and Week 6 | 
| Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment | Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline and 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment) | Baseline and Week 4 and Baseline and Week 6 | 
| Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment | Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment | Baseline and Week 2 | 
| Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment | Percent decrease from baseline in Body Surface Area treated (% BSA treated) from Baseline to after two weeks of treatment | Baseline and Week 2 | 
| Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment | Percent decrease in body surface area affected (%BSA affected) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment) | Baseline and Week 2 and Baseline and Week 4 | 
| Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment | Percent decrease from baseline in body surface area treated (%BSA treated) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment) | Baseline and Week 2 and Baseline and Week 4 | 
| Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment | Percent decrease in body surface area affected (%BSA affected) from Baseline two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment) | Baseline and Week 4 and Baseline and Week 6 | 
| Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment | Percent decrease in body surface area treated (%BSA treated) from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment) | Baseline and Week 4 and Baseline and Week 6 | 
| Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment | Number of Participants with Tolerability assessments (Pruritus, Telangiectasias, Stinging/Burning, Skin atrophy, Folliculitis) resulting in adverse events from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment) | Baseline and Week 4 and Baseline and Week 6 |