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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex® |
| |
| 2 | Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clobetasol Propionate, 0.05% | Drug | Apply twice daily for 2 or 4 weeks as monotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Change in Target Plaque Severity rating | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Self-Assessment of Quality of Life, Subject satisfaction | 4 weeks | |
| Safety - Evaluation of adverse events and tolerability | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Community Sample
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| Name | Affiliation | Role |
|---|---|---|
| Ronald W Gottschalk, MD | Galderma Laboratories, LP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DHC Dimensional HealthCare, Inc. (Clinical Research Organization) | Cedar Knolls | New Jersey | 76117 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Clobetasol propionate, 0.05% Spray | Drug | Apply twice daily for 2 or 4 weeks as add-on therapy |
|
|
| D011083 |
| Polycyclic Compounds |