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To demonstrate therapeutic equivalence and safety of Tapinarof Cream, 1% (Sun pharma Canada, Inc.) and Vtama® (Tapinarof) Cream, 1% in the treatment of plaque psoriasis.
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Tapinarof Cream, 1% (Sun pharma Canada, Inc.) and Vtama® (Tapinarof) Cream, 1% in the treatment of plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapinarof Cream, 1% | Experimental | The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. |
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| Vtama® (Tapinarof) Cream, 1% | Active Comparator | The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. |
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| Placebo Control | Placebo Comparator | The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapinarof Cream, 1% | Drug | The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Demonstration in Therapeutic Equivalence & Safety of the Investigational Product | The proportion of subjects in each treatment group with treatment success with a minimum 2-grade improvement. | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Yantovskiy | Sun Pharmaceuticals Industries, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Pharmaceutical Industries, Inc. | Hawthorne | New York | 10532 | United States |
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| ID | Term |
|---|---|
| C571829 | tapinarof |
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| Vtama® (Tapinarof) Cream, 1% | Drug | The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. |
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| Placebo Control | Drug | The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. |
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