A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Completed · Phase 3

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT00421993

Run by

Galderma R&D

People needed

1670

Starts

2006-10-01

Expected to finish

2007-12-01

Last updated by the study team

2021-02-18

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A clinical diagnosis of acne vulgaris with facial involvement.
• A minimum of 20 but not more than 50 Inflammatory lesions
• A minimum of 30 but not more than 100 Noninflammatory lesions
• A score of 3 (Moderate) on the Investigator's Global Assessment Scale.

You may not qualify if…

• More than one acne nodule or any acne cyst.
• Acne conglobata, acne fulminans, secondary acne, or severe acne.
• Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
• Underlying diseases that require the use of interfering topical or systemic therapy.
• Use of prohibited medications prior to the study unless appropriate washout period is documented
• Use of hormonal contraceptives solely for control of acne

Where it is running

• Dermatology Research of Arkansas — Little Rock, Arkansas, United States
• Associates in research, Inc. — Fresno, California, United States
• University of California, Irvine — Irvine, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc — Marina del Rey, California, United States
• Affiliated Research Institute — San Diego, California, United States
• University at San Francisco Medical Center — San Francisco, California, United States
• Radiant Research — Santa Rosa, California, United States
• Dr Weintraub James — Simi Valley, California, United States
• The George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Visions Clinical Research — West Palm Beach, Florida, United States
• Atlanta Dermatology and Vein Research Center — Alpharetta, Georgia, United States
• SKINQRI — Lincolnshire, Illinois, United States
• Welborn Clinic — Evansville, Indiana, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Dolby Research, LLC — Baton Rouge, Louisiana, United States
• Hamzavi Dermatology — Port Huron, Michigan, United States
• Somerset Skin Clinic — Troy, Michigan, United States
• James Del Rosso, DO - Office of Dr. James Del Russo — Henderson, Nevada, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Skin Specialty Group — New York, New York, United States
• Derm Research Center of NY, Inc. — Stony Brook, New York, United States
• Zoe Draelos — High Point, North Carolina, United States
• OU Health Sciences Center - Dept. of Dermatology — Oklahoma City, Oklahoma, United States
• Medical Affliated Research Center — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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