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Bioequivalence with Clinical Endpoints.
Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene/BP gel, 0.3%/2.5% | Experimental | Topical, once daily, for 84 days. |
|
| EPIDUO® FORTE | Active Comparator | Topical, once daily, for 84 days. |
|
| Placebo | Placebo Comparator | Topical, once daily, for 84 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene/BP gel, 0.3%/2.5% | Drug | Gel |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory lesion counts | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts | Week 12 |
| Change in non-inflammatory lesion counts | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response of success | The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catawba Research | http://catawbaresearch.com/contact/ | Study Chair |
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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 |
|---|---|
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| ID | Term |
|---|---|
| D001585 | Benzoyl Peroxide |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| EPIDUO® FORTE | Drug | Gel |
|
|
| Placebo | Drug | Gel |
|
|
| D009930 |
| Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000068816 | Adapalene |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |