A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
NCT ID: NCT00421993
Last Updated: 2021-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1670 participants
INTERVENTIONAL
2006-10-31
2007-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Adapalene/Benzoyl Peroxide Topical Gel
Adapalene/Benzoyl Peroxide
Topical Gel, One application daily in the evening for 12 weeks
2
Adapalene Topical Gel
Adapalene
Topical Gel,One application daily in the evening for 12 weeks
3
Benzoyl Peroxide Topical Gel
Benzoyl Peroxide
Topical Gel, one application daily in the evening for 12 weeks
4
Topical Gel Vehicle
Topical Gel Vehicle
Topical Gel Vehicle,one application daily in the evening for 12 weeks
Interventions
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Adapalene/Benzoyl Peroxide
Topical Gel, One application daily in the evening for 12 weeks
Adapalene
Topical Gel,One application daily in the evening for 12 weeks
Benzoyl Peroxide
Topical Gel, one application daily in the evening for 12 weeks
Topical Gel Vehicle
Topical Gel Vehicle,one application daily in the evening for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Galderma
Principal Investigators
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Michael Graeber, MD
Role: STUDY_DIRECTOR
Galderma R&D
Locations
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Medical Affliated Research Center
Huntsville, Alabama, United States
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
Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, United States
Radiant Research
Anderson, South Carolina, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States
Arlington Center for Dermatology
Arlington, Texas, United States
UTSW Medical Center at Dallas
Dallas, Texas, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Tanner Clinic
Layton, Utah, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
The Dermatology Centre
Calgary, Alberta, Canada
Stratica Medical
Edmonton, Alberta, Canada
Guildford Dermatology Specialists
Surrey, British Columbia, Canada
Derm Research @ 888 Inc.
Vancouver, British Columbia, Canada
Winnipeg Clinic
Winnipeg, Manitoba, Canada
Dermadvances Research
Winnipeg, Manitoba, Canada
Nexus clinical research
St. John's, Newfoundland and Labrador, Canada
NewLab Clinical Research
St. John's, Newfoundland and Labrador, Canada
Ultranova Skin care
Barrie, Ontario, Canada
Lynderm Research inc.
Markham, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
XLR8 Medical Research Inc.
Windsor, Ontario, Canada
Innovaderm Research Laval Inc.
Laval, Quebec, Canada
Innovaderm Research Inc
Montreal, Quebec, Canada
Siena Medical Research
Montreal, Quebec, Canada
Licca Clinical Research Institute
Augsburg, , Germany
Henrik Pres
Berlin, , Germany
Meike Schroeder
Berlin, , Germany
Beatrice Gerlach
Dresden, , Germany
Kloverkorn, Windfried
Gilching, , Germany
Otto-Von-Guericke-Universitat Magdeburg
Magdeburg, , Germany
Michael Sebastian
Mahlow, , Germany
Thomas Dirschka
Wuppertal, , Germany
Outpatient Dermatology Department DUH
Budapest, , Hungary
Margit Simola
Budapest, , Hungary
Outpatient Dermatilogy Department XIX District
Budapest, , Hungary
Waldemar Placek
Bydgoszcz, , Poland
DERMED Specjalistyczne Gabinety Lekarskie
Lodz, , Poland
Wojceiech Silny
Poznan, , Poland
Countries
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References
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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. doi: 10.1067/s0190-9622(03)01154-x.
Related Links
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Related Info
Other Identifiers
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RD.06.SPR.18088
Identifier Type: -
Identifier Source: org_study_id
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