A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
Public ClinicalTrials.gov record NCT00421993. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study. The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.
Study identification
- NCT ID
- NCT00421993
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,670 participants
Conditions and interventions
Conditions
Interventions
- Adapalene/Benzoyl Peroxide Drug
- Adapalene Drug
- Benzoyl Peroxide Drug
- Topical Gel Vehicle Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2006
- Primary completion
- Sep 30, 2007
- Completion
- Nov 30, 2007
- Last update posted
- Feb 17, 2021
2006 – 2007
United States locations
- U.S. sites
- 33
- U.S. states
- 21
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Affliated Research Center | Huntsville | Alabama | 35801 | — |
| Dermatology Research of Arkansas | Little Rock | Arkansas | 72205 | — |
| Associates in research, Inc. | Fresno | California | 93720 | — |
| University of California, Irvine | Irvine | California | 92697-1385 | — |
| Dermatology Research Associates | Los Angeles | California | 90045 | — |
| Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc | Marina del Rey | California | 90292 | — |
| Affiliated Research Institute | San Diego | California | 92108 | — |
| University at San Francisco Medical Center | San Francisco | California | 94143 | — |
| Radiant Research | Santa Rosa | California | 95405 | — |
| Dr Weintraub James | Simi Valley | California | 93065 | — |
| The George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | — |
| Visions Clinical Research | West Palm Beach | Florida | 33406 | — |
| Atlanta Dermatology and Vein Research Center | Alpharetta | Georgia | 30005 | — |
| SKINQRI | Lincolnshire | Illinois | 60069 | — |
| Welborn Clinic | Evansville | Indiana | 47713 | — |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | — |
| Dolby Research, LLC | Baton Rouge | Louisiana | 70809 | — |
| Hamzavi Dermatology | Port Huron | Michigan | 48060 | — |
| Somerset Skin Clinic | Troy | Michigan | 48084 | — |
| James Del Rosso, DO - Office of Dr. James Del Russo | Henderson | Nevada | 89052 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Skin Specialty Group | New York | New York | 10021 | — |
| Derm Research Center of NY, Inc. | Stony Brook | New York | 11790-2598 | — |
| Zoe Draelos | High Point | North Carolina | 27262 | — |
| OU Health Sciences Center - Dept. of Dermatology | Oklahoma City | Oklahoma | 73104 | — |
| Allergy, Asthma and Dermatology Research Center, LLC | Lake Oswego | Oregon | 97035 | — |
| Radiant Research | Anderson | South Carolina | 29621 | — |
| Dermatology Associates of Knoxville | Knoxville | Tennessee | 37934 | — |
| Arlington Center for Dermatology | Arlington | Texas | 76011 | — |
| UTSW Medical Center at Dallas | Dallas | Texas | 75390-9190 | — |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 | — |
| Tanner Clinic | Layton | Utah | 84041 | — |
| Fletcher Allen Health Care | Burlington | Vermont | 05401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00421993, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 17, 2021 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00421993 live on ClinicalTrials.gov.