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To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) to AKLIEF® Cream and both active treatments to a placebo control in the treatment of acne vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifarotene Cream 0.005% | Experimental | The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days. |
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| AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories) | Active Comparator | The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days. |
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| Placebo Control | Placebo Comparator | The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifarotene Cream 0.005% | Drug | The study medication will be self-applied topically, on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration in Therapeutic Equivalence & Safety of the Investigational Product | Percent change in the inflammatory (papules and pustules) & non-inflammatory (open and closed comedones) lesion counts | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Yantovskiy | Taro Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taro Pharmaceuticals USA Inc. | Hawthorne | New York | 10532 | United States |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C000629420 | trifarotene |
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| Placebo | Drug | The study medication will be self-applied topically, on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days |
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| AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories) | Drug | The study medication will be self-applied topically, on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days |
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