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Epiduo Pediatric Acne Study

Primary Purpose

Acne

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

adapalene/benzoyl peroxide

Topical Gel Vehicle

About this trial

This is an interventional treatment trial for Acne

Eligibility Criteria

9 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UAB Dermatology Clinical Research
Children's Hospital and Health Center Division of Pediatric and Adolescent Dermatology
Redwood Family Dermatology
FXM Research Miramar
Adult & Pediatric Dermatology
Dermatology Specialists Research
Henry Ford Health Systems Department of Dermatology
Dermcenter PC - Somerset Skin Centre
Minnesota Clinical Study Center A Division of Associated Skin Care Specialists, PA
Central Dermatology PC
Skin Specialists, PC
Zoe Draelos, MD
Department of Dermatology - Wake Forest University Health Sciences
Cininnati Children's Hospital
Haber Dermatology Clinical Research Center
Penn State Milton S. Hershey Medical Center - Penn State College of Medicine
Palmetto Clinical Trial Services, LLC
Dermatology Associates of Kingsport, PC
The University of Texas Health Sciences Center at Houston
Premier Clinical Research
Guildford Dermatology Specialists
Nexus Clinical Research
Ultranova Skincare
Lynderm Research, Inc
North Bay Dermatology Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

adapalene/benzoyl peroxide

Topical Gel Vehicle

Arm Description

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

Topical Gel Vehicle applied topically once daily for 12 weeks

Outcomes

Primary Outcome Measures

Success Rate

Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)

Change From Baseline in Total Lesion Counts

Secondary Outcome Measures

Percent Change in Total Lesion Counts From Baseline

Change in Inflammatory Lesion Counts From Baseline

Full Information

NCT ID

NCT01138735

First Posted

June 4, 2010

Last Updated

February 16, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT01138735

Brief Title

Epiduo Pediatric Acne Study

Official Title

A Multi-center, Randomized, Vehicle-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Administered Once Daily for the Treatment of Subjects 9 to 11 Years of Age With Acne Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

285 (Actual)

8. Arms, Groups, and Interventions

Arm Title

adapalene/benzoyl peroxide

Arm Type

Active Comparator

Arm Description

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

Arm Title

Topical Gel Vehicle

Arm Type

Placebo Comparator

Arm Description

Topical Gel Vehicle applied topically once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

adapalene/benzoyl peroxide

Other Intervention Name(s)

Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%

Intervention Description

daily topical application for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Topical Gel Vehicle

Intervention Description

daily topical application for 12 weeks

Primary Outcome Measure Information:

Title

Success Rate

Description

Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)

Time Frame

Baseline to Week 12 (Last Observation Carried Forward [LOCF])

Title

Change From Baseline in Total Lesion Counts

Time Frame

Baseline to Week 12 (LOCF)

Secondary Outcome Measure Information:

Title

Percent Change in Total Lesion Counts From Baseline

Time Frame

Baseline to Week 12 (LOCF)

Title

Change in Inflammatory Lesion Counts From Baseline

Time Frame

Baseline to Week 12 (LOCF)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: