Epiduo Pediatric Acne Study

February 16, 2021 updated by: Galderma R&D

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
285

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Guildford Dermatology Specialists
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1A 5E8
        • Nexus Clinical Research
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • Ultranova Skincare
      • Markham, Ontario, Canada, L3P 1A8
        • Lynderm Research, Inc
      • North Bay, Ontario, Canada, P1B 3Z7
        • North Bay Dermatology Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB Dermatology Clinical Research
    • California
      • San Diego, California, United States, 92123
        • Children's Hospital and Health Center Division of Pediatric and Adolescent Dermatology
      • Santa Rosa, California, United States, 95403
        • Redwood Family Dermatology
    • Florida
      • Miramar, Florida, United States, 33027
        • FXM Research Miramar
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Adult & Pediatric Dermatology
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Dermatology Specialists Research
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Systems Department of Dermatology
      • Troy, Michigan, United States, 48084
        • Dermcenter PC - Somerset Skin Centre
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Center A Division of Associated Skin Care Specialists, PA
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Central Dermatology PC
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists, PC
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Zoe Draelos, MD
      • Winston-Salem, North Carolina, United States, 27157
        • Department of Dermatology - Wake Forest University Health Sciences
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cininnati Children's Hospital
      • South Euclid, Ohio, United States, 44118
        • Haber Dermatology Clinical Research Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center - Penn State College of Medicine
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Palmetto Clinical Trial Services, LLC
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Dermatology Associates of Kingsport, PC
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Sciences Center at Houston
    • Washington
      • Spokane, Washington, United States, 99204
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: adapalene/benzoyl peroxide
Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
Drug: adapalene/benzoyl peroxide
daily topical application for 12 weeks
Other Names:
  • Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%
Placebo Comparator: Topical Gel Vehicle
Topical Gel Vehicle applied topically once daily for 12 weeks
Drug: Topical Gel Vehicle
daily topical application for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success Rate
Time Frame: 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)
Baseline to Week 12 (Last Observation Carried Forward [LOCF])
Change From Baseline in Total Lesion Counts
Time Frame: Baseline to Week 12 (LOCF)
Baseline to Week 12 (LOCF)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percent Change in Total Lesion Counts From Baseline
Time Frame: Baseline to Week 12 (LOCF)
Baseline to Week 12 (LOCF)
Change in Inflammatory Lesion Counts From Baseline
Time Frame: Baseline to Week 12 (LOCF)
Baseline to Week 12 (LOCF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galderma R&D

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ian Landells, MD, Nexus Clinical Research
  • Principal Investigator: William Werschler, MD, Premier Clinical Research
  • Principal Investigator: Adelaide Hebert, MD, The University of Texas Health Science Center, Houston
  • Principal Investigator: 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: 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: 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: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RD.06.SPR.18155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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