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To demonstrate the efficacy, therapeutic equivalence and safety of Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% (Taro Pharmaceuticals U.S.A., Inc.) and CABTREO Topical Gel in the treatment of acne vulgaris.
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide topical gel 0.15%;3.1%;1.2% to CABTREO (Clindamycin Phosphate, Adapalene, And Benzoyl Peroxide) topical gel in the treatment of acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% | Experimental | The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days. |
|
| CABTREO Topical Gel | Active Comparator | The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days. |
|
| Placebo Control | Placebo Comparator | The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% | Drug | The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days. |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate the Therapeutic Equivalence & Safety of the Investigational Product | Percent change in the inflammatory (papules and pustules) and the 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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| CABTREO Topical Gel | Drug | The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days. |
|
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| Placebo Control | Drug | The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days. |
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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 |
|---|---|
| C007084 | clindamycin phosphate |
| D000068816 | Adapalene |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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