Epiduo Pediatric Acne Study

Completed · Phase 4

Conditions studied: Acne

In brief

The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.

Key facts

Study ID

NCT01138735

Run by

Galderma R&D

People needed

285

Starts

2010-06-01

Expected to finish

2011-08-01

Last updated by the study team

2021-02-18

Who can join

Age: 9 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of acne vulgaris with facial involvement
• 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

You may not qualify if…

• Acne nodule or acne cyst
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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