Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
285 participants
INTERVENTIONAL
2010-06-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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adapalene/benzoyl peroxide
Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
adapalene/benzoyl peroxide
daily topical application for 12 weeks
Topical Gel Vehicle
Topical Gel Vehicle applied topically once daily for 12 weeks
Topical Gel Vehicle
daily topical application for 12 weeks
Interventions
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adapalene/benzoyl peroxide
daily topical application for 12 weeks
Topical Gel Vehicle
daily topical application for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale
* A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline
Exclusion Criteria
* Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment
* Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments
* Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study
9 Years
11 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Graeber, MD
Role: STUDY_DIRECTOR
Galderma R&D
Lorne Albrecht, MD
Role: PRINCIPAL_INVESTIGATOR
Guildford Dermatology Specialists
Zoe Draelos, MD
Role: PRINCIPAL_INVESTIGATOR
Zoe Draelos, MD
Lawrence Eichenfield, MD
Role: PRINCIPAL_INVESTIGATOR
Childrens Hospital and Health Center Division of Pediatric and Adolescent Dermatology
Boni Elewski, MD
Role: PRINCIPAL_INVESTIGATOR
UAB Dermatology Clinical Research
Alan Fleischer, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Dermatology Wake Forest University Health Sciences
Francisco Flores, MD
Role: PRINCIPAL_INVESTIGATOR
FXM Research Miramar
Joseph Fowler, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Specialists Research
Robert Haber, MD
Role: PRINCIPAL_INVESTIGATOR
Haber Dermatology Clinical Research Center
Adelaide Hebert, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Michael Heffernan, MD
Role: PRINCIPAL_INVESTIGATOR
Central Dermatology, PC
David Kaplan, MD
Role: PRINCIPAL_INVESTIGATOR
Adult & Pediatric Dermatology
Steven Kempers, MD
Role: PRINCIPAL_INVESTIGATOR
Minnesota Clinical Study Center A Division of Associated Skin Care Specialist, PA
Rodion Kunynetz, MD
Role: PRINCIPAL_INVESTIGATOR
Ultranova Skincare
Ian Landells, MD
Role: PRINCIPAL_INVESTIGATOR
Nexus Clinical Research
Charles Lynde, MD
Role: PRINCIPAL_INVESTIGATOR
Lynderm Research Inc.
Russell Mader, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Associates of Kingsport, PC
Lew Andrew Rosoph, MD
Role: PRINCIPAL_INVESTIGATOR
North Bay Dermatology Centre
Joel Schlessenger, MD
Role: PRINCIPAL_INVESTIGATOR
Skin Specialists, PC
Michael Spigarelli, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Linda Stein Gold, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health Systems - Department of Dermatology
Jeffrey Sugarman, MD
Role: PRINCIPAL_INVESTIGATOR
Redwood Family Dermatology
William Werschler, MD
Role: PRINCIPAL_INVESTIGATOR
Premier Clinical Research
Patricia Westmoreland, MD
Role: PRINCIPAL_INVESTIGATOR
Palmetto Clinical Trial Services, LLC
Andrea Zaenglein, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State Milton S. Hershey Medical Center - Penn State College of Medicine
George Murakawa, MD
Role: PRINCIPAL_INVESTIGATOR
Dermcenter PC; Somerset Skin Centre
Locations
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UAB Dermatology Clinical Research
Birmingham, Alabama, United States
Children's Hospital and Health Center Division of Pediatric and Adolescent Dermatology
San Diego, California, United States
Redwood Family Dermatology
Santa Rosa, California, United States
FXM Research Miramar
Miramar, Florida, United States
Adult & Pediatric Dermatology
Overland Park, Kansas, United States
Dermatology Specialists Research
Louisville, Kentucky, United States
Henry Ford Health Systems Department of Dermatology
Detroit, Michigan, United States
Dermcenter PC - Somerset Skin Centre
Troy, Michigan, United States
Minnesota Clinical Study Center A Division of Associated Skin Care Specialists, PA
Fridley, Minnesota, United States
Central Dermatology PC
St Louis, Missouri, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Zoe Draelos, MD
High Point, North Carolina, United States
Department of Dermatology - Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Cininnati Children's Hospital
Cincinnati, Ohio, United States
Haber Dermatology Clinical Research Center
South Euclid, Ohio, United States
Penn State Milton S. Hershey Medical Center - Penn State College of Medicine
Hershey, Pennsylvania, United States
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, United States
Dermatology Associates of Kingsport, PC
Kingsport, Tennessee, United States
The University of Texas Health Sciences Center at Houston
Houston, Texas, United States
Premier Clinical Research
Spokane, Washington, United States
Guildford Dermatology Specialists
Surrey, British Columbia, Canada
Nexus Clinical Research
St. John's, Newfoundland and Labrador, Canada
Ultranova Skincare
Barrie, Ontario, Canada
Lynderm Research, Inc
Markham, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
Countries
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Other Identifiers
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RD.06.SPR.18155
Identifier Type: -
Identifier Source: org_study_id
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