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

Condition(s) targeted: Acne Vulgaris

Intervention: Adapalene/Benzoyl Peroxide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Galderma

Official(s) and/or principal investigator(s):
Michael Graeber, MD, Study Director, Affiliation: Galderma

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Success Rate on the Investigator's Global Assessment

Change in Inflammatory Lesion Counts

Change in Noninflammatory Lesion Counts

Secondary outcome:

Percent Change in Lesion Counts (Inflammatory,Noninflammatory, Total)

Change in Investigator's Global Assessment (IGA)

Subject's Assessment of Acne

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Medical Affliated Research Center, Huntsville, Alabama 35801, United States

The Dermatology Centre, Calgary, Alberta T2S 3B3, Canada

Stratica Medical, Edmonton, Alberta T5K 1X3, Canada

Dermatology Research of Arkansas, Little Rock, Arkansas 72205, United States

Guildford Dermatology Specialists, Surrey, British Columbia BC V3R 6A7, Canada

Derm Research @ 888 Inc., Vancouver, British Columbia V5Z 3Y1, Canada

Dermatology Research Associates, Los Angeles, California 90045, United States

Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc, Marina Del Rey, California 90292, United States

Associates in research, Inc., Fresno, California 93720, United States

Affiliated Research Institute, San Diego, California 92108, United States

Radiant Research, Santa Rosa, California 95405, United States

University of California, Irvine, Irvine, California 92697-1385, United States

Dr Weintraub James, Simi Valley, California 93065, United States

University at San Francisco Medical Center, San Francisco, California 94143, United States

The George Washington University Medical Center, Washington, District of Columbia 20037, United States

Visions Clinical Research, West palm Beach, Florida 33406, United States

Atlanta Dermatology and Vein Research Center, Alpharetta, Georgia 30005, United States

SKINQRI, Lincolnshire, Illinois 60069, United States

Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana 46256, United States

Welborn Clinic, EVANSVILLE, Indiana 47713, United States

Dolby Research, LLC, Baton Rouge, Louisiana 70809, United States

Winnipeg Clinic, Winnipeg, Manitoba R3C 0N2, Canada

Dermadvances Research, Winnipeg, Manitoba R3C 1R4, Canada

Hamzavi Dermatology, Port Huron, Michigan 48060, United States

Somerset Skin Clinic, Troy, Michigan 48084, United States

James Del Rosso, DO - Office of Dr. James Del Russo, Henderson, Nevada 89052, United States

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States

Skin Specialty Group, New York, New York 10021, United States

Derm Research Center of NY, Inc., Stony Brook, New York 11790-2598, United States

Nexus clinical research, St. John's, Newfoundland and Labrador A1B 3E1, Canada

NewLab Clinical Research, St. John's, Newfoundland and Labrador A1B 4S8, Canada

Zoe Draelos, High Point, North Carolina 27262, United States

OU Health Sciences Center - Dept. of Dermatology, Oklahoma City, Oklahoma 73104, United States

XLR8 Medical Research Inc., Windsor, Ontario N8W 1E6, Canada

North Bay Dermatology Centre, North Bay, Ontario P1B 3Z7, Canada

Ultranova Skin care, Barrie, Ontario L4M 6L2, Canada

Lynderm Research inc., Markham, Ontario L3P 1A8, Canada

Allergy, Asthma and Dermatology Research Center, LLC, Lake Oswego, Oregon 97035, United States

Siena Medical Research, Montreal, Quebec H3G1C6, Canada

Innovaderm Research Laval Inc., Laval, Quebec H7S 2C6, Canada

Innovaderm Research Inc, Montreal, Quebec H2K 4L5, Canada

Radiant Research, Anderson, South Carolina 29621, United States

Dermatology Associates of Knoxville, Knoxville, Tennessee 37934, United States

Arlington Center for Dermatology, Arlington, Texas 76011, United States

UTSW Medical Center at Dallas, Dallas, Texas 75390-9190, United States

University of Texas Medical Branch at Galveston, Galveston, Texas 77555, United States

Tanner Clinic, Layton, Utah 84041, United States

Fletcher Allen Health Care, Burlington, Vermont 05401, United States

Related publications:

Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. Review.

Starting date: October 2006
Ending date: December 2007
Last updated: January 21, 2008