Epiduo Pediatric Acne Study

Phase 4

Completed

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

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Gel Vehicle	Topical Gel Vehicle	Topical Gel Vehicle applied topically once daily for 12 weeks
adapalene/benzoyl peroxide	adapalene/benzoyl peroxide	Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% 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
Change in Inflammatory Lesion Counts From Baseline	Baseline to Week 12 (LOCF)
Percent Change in Total Lesion Counts From Baseline	Baseline to Week 12 (LOCF)

Trial Locations

Locations (25)

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; 🇺🇸 Saint Louis, Missouri, United States

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