Clinical trial NCT00421993: A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne vulgaris
Adapalene
Benzoyl Peroxide
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 1670
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Success Rate on the Investigator's Global Assessment
timeFrame: at week 12
measure: Changes in Inflammatory Lesion Counts
timeFrame: from Baseline to week 12
measure: Changes in Noninflammatory Lesion Counts
timeFrame: from Baseline to week 12
Secondary outcomes:
measure: Percent Change in Inflammatory Lesion Counts
timeFrame: at week 12
measure: Percent Change in Noniflammatory Lesion Counts
timeFrame: at week 12
measure: Percent Change in Total Lesion Counts
timeFrame: at week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affliated Research Center
state: Alabama
city: Little Rock
country: United States
facility: Dermatology Research of Arkansas
state: Arkansas
city: Fresno
country: United States
facility: Associates in research, Inc.
state: California
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Marina Del Rey
country: United States
facility: Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: San Francisco
country: United States
facility: University at San Francisco Medical Center
state: California
city: Santa Rosa
country: United States
facility: Radiant Research
state: California
city: Simi Valley
country: United States
facility: Dr Weintraub James
state: California
city: Washington
country: United States
facility: The George Washington University Medical Center
state: District of Columbia
city: West Palm Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology and Vein Research Center
state: Georgia
city: Lincolnshire
country: United States
facility: SKINQRI
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Baton Rouge
country: United States
facility: Dolby Research, LLC
state: Louisiana
city: Port Huron
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Clinic
state: Michigan
city: Henderson
country: United States
facility: James Del Rosso, DO - Office of Dr. James Del Russo
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Skin Specialty Group
state: New York
city: Stony Brook
country: United States
facility: Derm Research Center of NY, Inc.
state: New York
city: High Point
country: United States
facility: Zoe Draelos
state: North Carolina
city: Oklahoma City
country: United States
facility: OU Health Sciences Center - Dept. of Dermatology
state: Oklahoma
city: Lake Oswego
country: United States
facility: Allergy, Asthma and Dermatology Research Center, LLC
state: Oregon
city: Anderson
country: United States
facility: Radiant Research
state: South Carolina
city: Knoxville
country: United States
facility: Dermatology Associates of Knoxville
state: Tennessee
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Dallas
country: United States
facility: UTSW Medical Center at Dallas
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Calgary
country: Canada
facility: The Dermatology Centre
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Surrey
country: Canada
facility: Guildford Dermatology Specialists
state: British Columbia
city: Vancouver
country: Canada
facility: Derm Research @ 888 Inc.
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: Winnipeg
country: Canada
facility: Dermadvances Research
state: Manitoba
city: St. John's
country: Canada
facility: Nexus clinical research
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: NewLab Clinical Research
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: Ultranova Skin care
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research inc.
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research Inc.
state: Ontario
city: Laval
country: Canada
facility: Innovaderm Research Laval Inc.
state: Quebec
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
city: Montreal
country: Canada
facility: Siena Medical Research
state: Quebec
city: Augsburg
country: Germany
facility: Licca Clinical Research Institute
city: Berlin
country: Germany
facility: Henrik Pres
city: Berlin
country: Germany
facility: Meike Schroeder
city: Dresden
country: Germany
facility: Beatrice Gerlach
city: Gilching
country: Germany
facility: Kloverkorn, Windfried
city: Magdeburg
country: Germany
facility: Otto-Von-Guericke-Universitat Magdeburg
city: Mahlow
country: Germany
facility: Michael Sebastian
city: Wuppertal
country: Germany
facility: Thomas Dirschka
city: Budapest
country: Hungary
facility: Outpatient Dermatology Department DUH
city: Budapest
country: Hungary
facility: Margit Simola
city: Budapest
country: Hungary
facility: Outpatient Dermatilogy Department XIX District
city: Bydgoszcz
country: Poland
facility: Waldemar Placek
city: Lodz
country: Poland
facility: DERMED Specjalistyczne Gabinety Lekarskie
city: Poznan
country: Poland
facility: Wojceiech Silny
Study officials:
affiliation: Galderma R&D
name: Michael Graeber, MD
role: STUDY_DIRECTOR
References:
citation: 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.