Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis

Study Overview
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Brief Summary
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The primary objectives of this study are to evaluate the safety & efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

Detailed Description
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Same as above.

Official Title
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A Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of a Consecutive Treatment Regimen of Clobetasol Propionate 0.05% Spray, Followed by Calcitriol Ointment 3µg/g, in the Management of Moderate to Severe Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: clobetasol propionate spray 0.05%
* Drug: calcitriol ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area Overall Disease Severity of at least 3 (moderate) Exclusion Criteria: Surface area involvement too large (>20% BSA) Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Treatment<br>clobetasol propionate spray 0.05% Other Names: Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily calcitriol ointment Other Names: Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily | Drug: clobetasol propionate spray 0.05%<br>* clobetasol propionate spray, 0.05%, applied topically twice daily<br>* Other names: Clobex® Spray 0.05%;Drug: calcitriol ointment<br>* calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Disease Severity Success (ODS) | Success was defined as a one-grade improvement in ODS from baseline. | 8 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Improvement Score |  | 2, 4, 8 and 12 weeks | 
| Signs of Psoriasis - Erythema |  | 2, 4, 8 and 12 weeks | 
| Signs of Psoriasis - Scaling |  | 2, 4, 8 and 12 weeks | 
| Signs of Psoriasis - Plaque Elevation |  | 2, 4, 8 and 12 weeks | 
| Percent Change From Baseline in Body Surface Area (% BSA) Affected |  | 2, 4, 8 and 12 weeks | 
| Overall Disease Severity |  | 2, 4, 8 and 12 weeks | 
| Tolerability Assessment - Pruritus |  | Baseline, 2, 4, 8 and 12 weeks | 
| Tolerability Assessment - Telangiectasias |  | Baseline, 2, 4, 8 and 12 weeks | 
| Tolerability Assessment - Stinging/ Burning |  | Baseline, 2, 4, 8 and 12 weeks | 
| Tolerability Assessment - Skin Atrophy |  | Baseline, 2, 4, 8 and 12 weeks | 
| Tolerability Assessment - Folliculitis |  | Baseline, 2, 4, 8 and 12 weeks |