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To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.
Multi-center, double-blind, randomized, placebo controlled, parallel-group study comparing test and reference products to a placebo control in the treatment of scalp psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental | Betamethasone Scalp Suspension 0.064%;0.0005% (Taro Pharmaceuticals Inc.) |
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| Reference Product | Active Comparator | Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA) |
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| Placebo | Placebo Comparator | Vehicle of the test product (Taro Pharmaceuticals Inc.) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone Scalp Suspension 0.064%;0.0005% | Drug | applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| treatment success on the Physician's Global Assessment (PGA) of disease severity | The proportion of subjects in each treatment group with "treatment success" (defined as none or minimal, a score of 0 or 1, within the treatment area) on the PGA of disease severity | Study Week 4 (Day 28 ± 4 days) |
| clinical success on the Physician's Global Assessment (PASI) of disease severity | The proportion of subjects in each treatment group with "clinical success" (defined as clear or almost clear, a score of 0 or 1, at the target lesion site) on the PASI. Each psoriatic sign of scaling, erythema and plaque elevation should have a score of 0 or 1 for the subject to be considered a clinical success. The target lesion is to be identified at Baseline as the most severe lesion. | Study Week 4 (Day 28 ± 4 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Yantovskiy | Taro Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catawba Research, LLC | Charlotte | North Carolina | 28217 | United States |
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| ID | Term |
|---|---|
| C517164 | betamethasone dipropionate, calcipotriol drug combination |
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| Taclonex® | Drug | applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks. |
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| Placebo topical suspension | Drug | applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks. |
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