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To demonstrate therapeutic equivalence and safety of adapalene gel 0.1% (Taro Pharmaceuticals U.S.A., Inc.) and Differin® Gel (Adapalene Gel 0.1%, Galderma) in the treatment of acne vulgaris.
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, Adapalene Gel 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and to Differin® Gel (Adapalene 0.1%, Galderma) and both active treatments to a placebo control in the treatment of acne vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene gel 0.1% | Experimental | 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. |
|
| Differin® Gel (Adapalene 0.1%, Galderma) | Active Comparator | 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. |
|
| Placebo Control | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene Gel 0.1% | 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 |
|---|---|---|
| The percentage change in the inflammatory and non-inflammatory lesion counts | Demonstration of Therapeutic Equivalence | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zaidoon A. Al-Zubaidy | Catawba Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catawba Research, LLC | Charlotte | North Carolina | 28217 | 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 |
|---|---|
| D000068816 | Adapalene |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo Control | 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. |
|
|
| Differin® Gel (Adapalene 0.1%, Galderma) | 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. |
|
|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |