A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
- Conditions
- Acne Vulgaris
- Interventions
- Registration Number
- NCT00421993
- Lead Sponsor
- Galderma R&D
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1670
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Adapalene/Benzoyl Peroxide Adapalene/Benzoyl Peroxide Topical Gel 4 Topical Gel Vehicle Topical Gel Vehicle 2 Adapalene Adapalene Topical Gel 3 Benzoyl Peroxide Benzoyl Peroxide Topical Gel
- Primary Outcome Measures
Name Time Method Changes in Noninflammatory Lesion Counts from Baseline to week 12 Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count
Success Rate on the Investigator's Global Assessment at week 12 Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)
Changes in Inflammatory Lesion Counts from Baseline to week 12 Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts
- Secondary Outcome Measures
Name Time Method Percent Change in Inflammatory Lesion Counts at week 12 Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Percent Change in Noniflammatory Lesion Counts at week 12 Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Percent Change in Total Lesion Counts at week 12 Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Trial Locations
- Locations (61)
UTSW Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Dolby Research, LLC
🇺🇸Baton Rouge, Louisiana, United States
SKINQRI
🇺🇸Lincolnshire, Illinois, United States
Associates in research, Inc.
🇺🇸Fresno, California, United States
Medical Affliated Research Center
🇺🇸Huntsville, Alabama, United States
Affiliated Research Institute
🇺🇸San Diego, California, United States
Dermatology Research of Arkansas
🇺🇸Little Rock, Arkansas, United States
Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc
🇺🇸Marina Del Rey, California, United States
XLR8 Medical Research Inc.
🇨🇦Windsor, Ontario, Canada
Waldemar Placek
🇵🇱Bydgoszcz, Poland
Wojceiech Silny
🇵🇱Poznan, Poland
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Dermadvances Research
🇨🇦Winnipeg, Manitoba, Canada
Atlanta Dermatology and Vein Research Center
🇺🇸Alpharetta, Georgia, United States
Innovaderm Research Laval Inc.
🇨🇦Laval, Quebec, Canada
Lynderm Research inc.
🇨🇦Markham, Ontario, Canada
Allergy, Asthma and Dermatology Research Center, LLC
🇺🇸Lake Oswego, Oregon, United States
Skin Specialty Group
🇺🇸New York, New York, United States
Beatrice Gerlach
🇩🇪Dresden, Germany
Winnipeg Clinic
🇨🇦Winnipeg, Manitoba, Canada
Zoe Draelos
🇺🇸High Point, North Carolina, United States
University at San Francisco Medical Center
🇺🇸San Francisco, California, United States
OU Health Sciences Center - Dept. of Dermatology
🇺🇸Oklahoma City, Oklahoma, United States
Innovaderm Research Inc
🇨🇦Montreal, Quebec, Canada
Siena Medical Research
🇨🇦Montreal, Quebec, Canada
Nexus clinical research
🇨🇦St. John's, Newfoundland and Labrador, Canada
NewLab Clinical Research
🇨🇦St. John's, Newfoundland and Labrador, Canada
Henrik Pres
🇩🇪Berlin, Germany
Otto-Von-Guericke-Universitat Magdeburg
🇩🇪Magdeburg, Germany
Michael Sebastian
🇩🇪Mahlow, Germany
University of California, Irvine
🇺🇸Irvine, California, United States
Meike Schroeder
🇩🇪Berlin, Germany
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Visions Clinical Research
🇺🇸West Palm Beach, Florida, United States
The George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States
Hamzavi Dermatology
🇺🇸Port Huron, Michigan, United States
James Del Rosso, DO - Office of Dr. James Del Russo
🇺🇸Henderson, Nevada, United States
Somerset Skin Clinic
🇺🇸Troy, Michigan, United States
Derm Research Center of NY, Inc.
🇺🇸Stony Brook, New York, United States
Dermatology Associates of Knoxville
🇺🇸Knoxville, Tennessee, United States
Arlington Center for Dermatology
🇺🇸Arlington, Texas, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
The Dermatology Centre
🇨🇦Calgary, Alberta, Canada
Derm Research @ 888 Inc.
🇨🇦Vancouver, British Columbia, Canada
Stratica Medical
🇨🇦Edmonton, Alberta, Canada
Guildford Dermatology Specialists
🇨🇦Surrey, British Columbia, Canada
Ultranova Skin care
🇨🇦Barrie, Ontario, Canada
Outpatient Dermatilogy Department XIX District
🇭🇺Budapest, Hungary
DERMED Specjalistyczne Gabinety Lekarskie
🇵🇱Lodz, Poland
Thomas Dirschka
🇩🇪Wuppertal, Germany
Margit Simola
🇭🇺Budapest, Hungary
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Kloverkorn, Windfried
🇩🇪Gilching, Germany
Dr Weintraub James
🇺🇸Simi Valley, California, United States
Licca Clinical Research Institute
🇩🇪Augsburg, Germany
University of Texas Medical Branch at Galveston
🇺🇸Galveston, Texas, United States
Welborn Clinic
🇺🇸Evansville, Indiana, United States
North Bay Dermatology Centre
🇨🇦North Bay, Ontario, Canada
Outpatient Dermatology Department DUH
🇭🇺Budapest, Hungary
Radiant Research
🇺🇸Anderson, South Carolina, United States