Epiduo Pediatric Acne Study

Phase 4

Completed

• Conditions: Acne
• Interventions: Drug: adapalene/benzoyl peroxide; Drug: Topical Gel Vehicle

• Registration Number: NCT01138735
• Lead Sponsor: Galderma R&D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Disposition First Submitted: 2012-05-07
• Disposition First Submitted QC: 2012-05-07
• Disposition First Posted: 2012-05-10
• Results First Submitted: 2013-02-19
• Results First Submitted QC: 2013-02-19
• Results First Posted: 2013-03-26
• Status Verified: 2013-04
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adapalene/benzoyl peroxide	adapalene/benzoyl peroxide	Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
Topical Gel Vehicle	Topical Gel Vehicle	Topical Gel Vehicle applied topically once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Total Lesion Counts	Baseline to Week 12 (LOCF)
Success Rate	Baseline to Week 12 (Last Observation Carried Forward [LOCF])	Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)

Secondary Outcome Measures

Name	Time	Method
Percent Change in Total Lesion Counts From Baseline	Baseline to Week 12 (LOCF)
Change in Inflammatory Lesion Counts From Baseline	Baseline to Week 12 (LOCF)

Trial Locations

Locations (25)

FXM Research Miramar; 🇺🇸 Miramar, Florida, United States

Henry Ford Health Systems Department of Dermatology; 🇺🇸 Detroit, Michigan, United States

Dermcenter PC - Somerset Skin Centre; 🇺🇸 Troy, Michigan, United States

Skin Specialists, PC; 🇺🇸 Omaha, Nebraska, United States

Dermatology Associates of Kingsport, PC; 🇺🇸 Kingsport, Tennessee, United States

Palmetto Clinical Trial Services, LLC; 🇺🇸 Greenville, South Carolina, United States

Guildford Dermatology Specialists; 🇨🇦 Surrey, British Columbia, Canada

Nexus Clinical Research; 🇨🇦 St John's, Newfoundland and Labrador, Canada

North Bay Dermatology Centre; 🇨🇦 North Bay, Ontario, Canada

Adult & Pediatric Dermatology; 🇺🇸 Overland Park, Kansas, United States

Minnesota Clinical Study Center A Division of Associated Skin Care Specialists, PA; 🇺🇸 Fridley, Minnesota, United States

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

Dermatology Specialists Research; 🇺🇸 Louisville, Kentucky, United States

Department of Dermatology - Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Central Dermatology PC; 🇺🇸 Saint Louis, Missouri, United States

Zoe Draelos, MD; 🇺🇸 High Point, 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

The University of Texas Health Sciences Center at Houston; 🇺🇸 Houston, Texas, United States

Premier Clinical Research; 🇺🇸 Spokane, Washington, United States

Ultranova Skincare; 🇨🇦 Barrie, Ontario, Canada

Lynderm Research, Inc; 🇨🇦 Markham, Ontario, Canada