Efficacy, Tolerance and Satisfaction With CLOBEX® Spray When Used as Monotherapy or Add-on Therapy in Plaque Psoriasis

Study Overview
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Brief Summary
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Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents.

Detailed Description
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Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in the target plaque severity (TPS) rating between Weeks 0 and 4.

Official Title
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Phase 4 Open-Label Multicenter Community-based 4-Wk Trial to Assess Efficacy, Tolerance to Tx & Patient Satisfaction w/ CLOBEX® Spray When Used as Mono- or Add-on Therapy to Existing Systemic/Topical Agents for Tx of Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Clobetasol Propionate, 0.05%
* Drug: Clobetasol propionate, 0.05% Spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe plaque psoriasis between 3% and 20% of Body Surface Area (BSA) with a target plaque severity (TPS) of moderate to severe At least 1 target site (not on the palms or soles of the feet) with a TPS rating of moderate to severe and with 1 or more elevated, easily palpable, plaques having well-circumscribed margins, and at least 1 cm in diameter History of stable plaque psoriasis of greater than or equal to 3 months Exclusion Criteria: Diagnosis of guttate, generalized pustular, erythrodermic, psoriatic arthritis, or nail psoriasis as the sole or predominant form of psoriasis Psoriatic arthritis that was not stable or might have required a change in medication during the 4-week study period Plaque psoriasis requiring treatment on the face, scalp, neck, groin, and armpits

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex® | Drug: Clobetasol Propionate, 0.05%<br>* Apply twice daily for 2 or 4 weeks as monotherapy<br>* Other names: Clobex® Spray, 0.05%;|
| 2<br>Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment | Drug: Clobetasol propionate, 0.05% Spray<br>* Apply twice daily for 2 or 4 weeks as add-on therapy<br>* Other names: Clobex® Spray, 0.05%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Change in Target Plaque Severity rating |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Self-Assessment of Quality of Life, Subject satisfaction |  | 4 weeks | 
| Safety - Evaluation of adverse events and tolerability |  | 4 weeks |