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

Sponsor:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00421993

Purpose

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.

Condition	Intervention	Phase
Acne Vulgaris	Drug: Adapalene/Benzoyl Peroxide Drug: Adapalene Drug: Benzoyl Peroxide Drug: Topical Gel Vehicle	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide Adapalene

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

Success Rate on the Investigator's Global Assessment [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
Changes in Inflammatory Lesion Counts [ Time Frame: from Baseline to week 12 ] [ Designated as safety issue: No ]
Changes in Noninflammatory Lesion Counts [ Time Frame: from Baseline to week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent Change in Inflammatory Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
Percent Change in Noniflammatory Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
Percent Change in Total Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

Enrollment:	1670
Study Start Date:	October 2006
Study Completion Date:	December 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Adapalene/Benzoyl Peroxide Topical Gel	Drug: Adapalene/Benzoyl Peroxide Topical Gel, One application daily in the evening for 12 weeks
2: Active Comparator Adapalene Topical Gel	Drug: Adapalene Topical Gel,One application daily in the evening for 12 weeks
3: Active Comparator Benzoyl Peroxide Topical Gel	Drug: Benzoyl Peroxide Topical Gel, one application daily in the evening for 12 weeks
4: Placebo Comparator Topical Gel Vehicle	Drug: Topical Gel Vehicle Topical Gel Vehicle,one application daily in the evening for 12 weeks

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421993

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Locations

United States, Alabama
Medical Affliated Research Center
Huntsville, Alabama, United States, 35801
United States, Arkansas
Dermatology Research of Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
Radiant Research
Santa Rosa, California, United States, 95405
Associates in research, Inc.
Fresno, California, United States, 93720
Affiliated Research Institute
San Diego, California, United States, 92108
Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc
Marina Del Rey, California, United States, 90292
University of California, Irvine
Irvine, California, United States, 92697-1385
Dr Weintraub James
Simi Valley, California, United States, 93065
University at San Francisco Medical Center
San Francisco, California, United States, 94143
United States, District of Columbia
The George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
Visions Clinical Research
West palm Beach, Florida, United States, 33406
United States, Georgia
Atlanta Dermatology and Vein Research Center
Alpharetta, Georgia, United States, 30005
United States, Illinois
SKINQRI
Lincolnshire, Illinois, United States, 60069
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
Welborn Clinic
EVANSVILLE, Indiana, United States, 47713
United States, Louisiana
Dolby Research, LLC
Baton Rouge, Louisiana, United States, 70809
United States, Michigan
Hamzavi Dermatology
Port Huron, Michigan, United States, 48060
Somerset Skin Clinic
Troy, Michigan, United States, 48084
United States, Nevada
James Del Rosso, DO - Office of Dr. James Del Russo
Henderson, Nevada, United States, 89052
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Skin Specialty Group
New York, New York, United States, 10021
Derm Research Center of NY, Inc.
Stony Brook, New York, United States, 11790-2598
United States, North Carolina
Zoe Draelos
High Point, North Carolina, United States, 27262
United States, Oklahoma
OU Health Sciences Center - Dept. of Dermatology
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, United States, 97035
United States, South Carolina
Radiant Research
Anderson, South Carolina, United States, 29621
United States, Tennessee
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States, 37934
United States, Texas
Arlington Center for Dermatology
Arlington, Texas, United States, 76011
UTSW Medical Center at Dallas
Dallas, Texas, United States, 75390-9190
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
United States, Utah
Tanner Clinic
Layton, Utah, United States, 84041
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
Canada, Alberta
The Dermatology Centre
Calgary, Alberta, Canada, T2S 3B3
Stratica Medical
Edmonton, Alberta, Canada, T5K 1X3
Canada, British Columbia
Guildford Dermatology Specialists
Surrey, British Columbia, Canada, BC V3R 6A7
Derm Research @ 888 Inc.
Vancouver, British Columbia, Canada, V5Z 3Y1
Canada, Manitoba
Winnipeg Clinic
Winnipeg, Manitoba, Canada, R3C 0N2
Dermadvances Research
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, Newfoundland and Labrador
Nexus clinical research
St. John's, Newfoundland and Labrador, Canada, A1B 3E1
NewLab Clinical Research
St. John's, Newfoundland and Labrador, Canada, A1B 4S8
Canada, Ontario
XLR8 Medical Research Inc.
Windsor, Ontario, Canada, N8W 1E6
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B 3Z7
Ultranova Skin care
Barrie, Ontario, Canada, L4M 6L2
Lynderm Research inc.
Markham, Ontario, Canada, L3P 1A8
Canada, Quebec
Siena Medical Research
Montreal, Quebec, Canada, H3G1C6
Innovaderm Research Laval Inc.
Laval, Quebec, Canada, H7S 2C6
Innovaderm Research Inc
Montreal, Quebec, Canada, H2K 4L5
Germany
Beatrice Gerlach
Dresden, Germany, 01097
Michael Sebastian
Mahlow, Germany, 15831
Otto-Von-Guericke-Universitat Magdeburg
Magdeburg, Germany, 39120
Meike Schroeder
Berlin, Germany, 14169
Henrik Pres
Berlin, Germany, 10435
Thomas Dirschka
Wuppertal, Germany, 42275
Kloverkorn, Windfried
Gilching, Germany, 82205
Licca Clinical Research Institute
Augsburg, Germany, 86179
Hungary
Outpatient Dermatilogy Department XIX District
Budapest, Hungary, 1195
Margit Simola
Budapest, Hungary, 1084
Outpatient Dermatology Department DUH
Budapest, Hungary, 1036
Poland
DERMED Specjalistyczne Gabinety Lekarskie
Lodz, Poland, 90265
Waldemar Placek
Bydgoszcz, Poland, 85096
Wojceiech Silny
Poznan, Poland, 60355

Sponsors and Collaborators

Galderma

Investigators

Study Director:

Michael Graeber, MD

Galderma

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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.

Responsible Party:	Galderma ( Michael Graeber, MD, Head of US Development )
Study ID Numbers:	RD.06.SPR.18088
Study First Received:	January 11, 2007
Results First Received:	January 15, 2009
Last Updated:	October 19, 2009
ClinicalTrials.gov Identifier:	NCT00421993 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Galderma:

Acne vulgaris
Adapalene
Benzoyl Peroxide

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Facial Dermatoses
Skin Diseases
Physiological Effects of Drugs
Benzoyl Peroxide
Sebaceous Gland Diseases
Adapalene
Acne Vulgaris
Pharmacologic Actions
Sensory System Agents

Acneiform Eruptions
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on November 27, 2009