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The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene BPO | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit | ||
| Global severity assessment at each post Baseline visit |
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Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/exclusion criteria.
Main inclusion criteria:
Main exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth ARTHUR, MD | Helendale Dermatology - Rochester NY - 585-266-5420 | |
| Alicia BUCKO, MD | Academic Dermatology Associates - Albuquerque NM - 505-247-4220 | |
| Paul YAMAUCHI, MD | Clinical Research Specialists, Inc. - Santa Monica CA - 310-828-8887 | |
| Steven E. KEMPERS, MD | Minnesota Clinical Study Center - Fridley MN - 763-571-4200 | |
| Harald GOLLNICK, MD | Otto-von-Guericke University - Magdeburg - Germany | Principal Investigator |
| Yvonne FRAMBACH, MD | Universitatsklinikum - Lubeck - Germany | |
| Michael MEURER, MD | Dresden University - Dresden - Germany | |
| Christos ZOUBOULIS, MD | Hautklinik und Immunologisches Zentrum des Städtischen Klinikum - Dessau - Germany | |
| Roland KAUFMANN, MD | Zentrum fur Dermatoligie und Venerologie - Frankfurt - Germany | |
| Thomas SCHWARZ, MD | Klinik fur Dermatologie, Venerologie und Allerologie - Kiel - Germany |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paul YAMAUCHI | Santa Monica | California | 90404 | United States | ||
| Steven E. KEMPERS |
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| Label | URL |
|---|---|
| Related Info | View source |
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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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| Fridley |
| Minnesota |
| 55432 |
| United States |
| Dr Alicia BUCKO | Albuquerque | New Mexico | 87106 | United States |
| Elisabeth ARTHUR | Rochester | New York | 14609 | United States |