NCT01138735

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2010

Geographic Reach
2 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 26, 2013

Completed
Last Updated

February 18, 2021

Status Verified

April 1, 2013

Enrollment Period

1.2 years

First QC Date

June 4, 2010

Results QC Date

February 19, 2013

Last Update Submit

February 16, 2021

Conditions

Acne

Outcome Measures

Primary Outcomes (2)

  • 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)

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

  • Change From Baseline in Total Lesion Counts

    Baseline to Week 12 (LOCF)

Secondary Outcomes (2)

  • 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)

Study Arms (2)

adapalene/benzoyl peroxide

ACTIVE COMPARATOR

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

Drug: adapalene/benzoyl peroxide

Topical Gel Vehicle

PLACEBO COMPARATOR

Topical Gel Vehicle applied topically once daily for 12 weeks

Drug: Topical Gel Vehicle

Interventions

adapalene/benzoyl peroxideDRUG

daily topical application for 12 weeks

Also known as: Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%
adapalene/benzoyl peroxide
Topical Gel VehicleDRUG

daily topical application for 12 weeks

Topical Gel Vehicle

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

UAB Dermatology Clinical Research

Birmingham, Alabama, 35233, United States

Location

Children's Hospital and Health Center Division of Pediatric and Adolescent Dermatology

San Diego, California, 92123, United States

Location

Redwood Family Dermatology

Santa Rosa, California, 95403, United States

Location

FXM Research Miramar

Miramar, Florida, 33027, United States

Location

Adult & Pediatric Dermatology

Overland Park, Kansas, 66211, United States

Location

Dermatology Specialists Research

Louisville, Kentucky, 40202, United States

Location

Henry Ford Health Systems Department of Dermatology

Detroit, Michigan, 48202, United States

Location

Dermcenter PC - Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Minnesota Clinical Study Center A Division of Associated Skin Care Specialists, PA

Fridley, Minnesota, 55432, United States

Location

Central Dermatology PC

St Louis, Missouri, 63117, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Zoe Draelos, MD

High Point, North Carolina, 27262, United States

Location

Department of Dermatology - Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Cininnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Haber Dermatology Clinical Research Center

South Euclid, Ohio, 44118, United States

Location

Penn State Milton S. Hershey Medical Center - Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Palmetto Clinical Trial Services, LLC

Greenville, South Carolina, 29607, United States

Location

Dermatology Associates of Kingsport, PC

Kingsport, Tennessee, 37660, United States

Location

The University of Texas Health Sciences Center at Houston

Houston, Texas, 77030, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

Guildford Dermatology Specialists

Surrey, British Columbia, V3R 6A7, Canada

Location

Nexus Clinical Research

St. John's, Newfoundland and Labrador, A1A 5E8, Canada

Location

Ultranova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

Lynderm Research, Inc

Markham, Ontario, L3P 1A8, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene, Benzoyl Peroxide Drug CombinationAdapaleneBenzoyl PeroxideGels

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

BenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsColloidsComplex MixturesDosage Forms

Limitations and Caveats

LOCF data were used for primary efficacy and secondary efficacy data.

Results Point of Contact

Title
Michael Graeber, MD
Organization
Galderma
michael.graeber@galderma.com
609-860-8201

Study Officials

  • Michael Graeber, MD

    Galderma R&D

    STUDY DIRECTOR

  • Lorne Albrecht, MD

    Guildford Dermatology Specialists

    PRINCIPAL INVESTIGATOR

  • Zoe Draelos, MD

    Zoe Draelos, MD

    PRINCIPAL INVESTIGATOR

  • Lawrence Eichenfield, MD

    Childrens Hospital and Health Center Division of Pediatric and Adolescent Dermatology

    PRINCIPAL INVESTIGATOR

  • Boni Elewski, MD

    UAB Dermatology Clinical Research

    PRINCIPAL INVESTIGATOR

  • Alan Fleischer, MD

    Department of Dermatology Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

  • Francisco Flores, MD

    FXM Research Miramar

    PRINCIPAL INVESTIGATOR

  • Joseph Fowler, MD

    Dermatology Specialists Research

    PRINCIPAL INVESTIGATOR

  • Robert Haber, MD

    Haber Dermatology Clinical Research Center

    PRINCIPAL INVESTIGATOR

  • Adelaide Hebert, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

  • Michael Heffernan, MD

    Central Dermatology, PC

    PRINCIPAL INVESTIGATOR

  • David Kaplan, MD

    Adult & Pediatric Dermatology

    PRINCIPAL INVESTIGATOR

  • Steven Kempers, MD

    Minnesota Clinical Study Center A Division of Associated Skin Care Specialist, PA

    PRINCIPAL INVESTIGATOR

  • Rodion Kunynetz, MD

    Ultranova Skincare

    PRINCIPAL INVESTIGATOR

  • Ian Landells, MD

    Nexus Clinical Research

    PRINCIPAL INVESTIGATOR

  • Charles Lynde, MD

    Lynderm Research Inc.

    PRINCIPAL INVESTIGATOR

  • Russell Mader, MD

    Dermatology Associates of Kingsport, PC

    PRINCIPAL INVESTIGATOR

  • Lew Andrew Rosoph, MD

    North Bay Dermatology Centre

    PRINCIPAL INVESTIGATOR

  • Joel Schlessenger, MD

    Skin Specialists, PC

    PRINCIPAL INVESTIGATOR

  • Michael Spigarelli, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

  • Linda Stein Gold, MD

    Henry Ford Health Systems - Department of Dermatology

    PRINCIPAL INVESTIGATOR

  • Jeffrey Sugarman, MD

    Redwood Family Dermatology

    PRINCIPAL INVESTIGATOR

  • William Werschler, MD

    Premier Clinical Research

    PRINCIPAL INVESTIGATOR

  • Patricia Westmoreland, MD

    Palmetto Clinical Trial Services, LLC

    PRINCIPAL INVESTIGATOR

  • Andrea Zaenglein, MD

    Penn State Milton S. Hershey Medical Center - Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

  • George Murakawa, MD

    Dermcenter PC; Somerset Skin Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 7, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 18, 2021

Results First Posted

March 26, 2013

Record last verified: 2013-04

Locations

US(20)CA(5)