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To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream
Same as above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Differin® Gel, 0.1% for 12 weeks |
|
| 2 | Active Comparator | Tazorac® Cream, 0.1% for 12 weeks |
|
| 3 | Active Comparator | Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene Gel, 0.1% | Drug | Apply once daily in the evening for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - total lesion counts | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - tolerability assessments and adverse event reporting | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald W Gottschalk, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | 92123 | United States | ||
| Henry Ford Medical Center-Dept. of Dermatology |
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| Tazarotene Cream, 0.1% | Drug | Apply once daily in the evening for 12 weeks |
|
|
| Adapalene Gel, 0.1% + Tazarotene Cream, 0.1% | Drug | Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks |
|
|
| Detroit |
| Michigan |
| 48202 |
| United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| State University of New York Downstate Medical Center-Dept. of Dermatology | Brooklyn | New York | 11203 | United States |
| Dermatology Research Associates | Cincinnati | Ohio | 45230 | United States |
| Phoebe Rich, MD & Associates | Portland | Oregon | 97210 | United States |
| Milton S. Hershey Medical Center Center-Div. of Dermatology | Hershey | Pennsylvania | 17033-0850 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| J & S Studies, Inc. | Bryan | Texas | 77802 | United States |
| Stephens & Associates | Carrollton | Texas | 75006 | United States |
| Dermatology Research Center | Salt Lake City | Utah | 84124 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| 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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