A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

February 16, 2021 updated by: Galderma R&D

A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.

The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1670

Phase

  • Phase 3

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
    • Alberta
      • Calgary, Alberta, Canada, T2S 3B3
        • The Dermatology Centre
      • Edmonton, Alberta, Canada, T5K 1X3
        • Stratica Medical
    • British Columbia
      • Surrey, British Columbia, Canada, BC V3R 6A7
        • Guildford Dermatology Specialists
      • Vancouver, British Columbia, Canada, V5Z 3Y1
        • Derm Research @ 888 Inc.
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Winnipeg Clinic
      • Winnipeg, Manitoba, Canada, R3C 1R4
        • Dermadvances Research
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3E1
        • Nexus Clinical Research
      • St. John's, Newfoundland and Labrador, Canada, A1B 4S8
        • NewLab Clinical Research
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • Ultranova Skin care
      • Markham, Ontario, Canada, L3P 1A8
        • Lynderm Research Inc.
      • North Bay, Ontario, Canada, P1B 3Z7
        • North Bay Dermatology Centre
      • Windsor, Ontario, Canada, N8W 1E6
        • XLR8 Medical Research Inc.
    • Quebec
      • Laval, Quebec, Canada, H7S 2C6
        • Innovaderm Research Laval Inc.
      • Montreal, Quebec, Canada, H2K 4L5
        • Innovaderm Research Inc
      • Montreal, Quebec, Canada, H3G1C6
        • Siena Medical Research
  • Germany
      • Augsburg, Germany, 86179
        • Licca Clinical Research Institute
      • Berlin, Germany, 10435
        • Henrik Pres
      • Berlin, Germany, 14169
        • Meike Schroeder
      • Dresden, Germany, 01097
        • Beatrice Gerlach
      • Gilching, Germany, 82205
        • Kloverkorn, Windfried
      • Magdeburg, Germany, 39120
        • Otto-von-Guericke-Universitat Magdeburg
      • Mahlow, Germany, 15831
        • Michael Sebastian
      • Wuppertal, Germany, 42275
        • Thomas Dirschka
  • Hungary
      • Budapest, Hungary, 1036
        • Outpatient Dermatology Department DUH
      • Budapest, Hungary, 1084
        • Margit Simola
      • Budapest, Hungary, 1195
        • Outpatient Dermatilogy Department XIX District
  • Poland
      • Bydgoszcz, Poland, 85096
        • Waldemar Placek
      • Lodz, Poland, 90265
        • DERMED Specjalistyczne Gabinety Lekarskie
      • Poznan, Poland, 60355
        • Wojceiech Silny
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affliated Research Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Dermatology Research of Arkansas
    • California
      • Fresno, California, United States, 93720
        • Associates In Research, Inc.
      • Irvine, California, United States, 92697-1385
        • University of California, Irvine
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Marina Del Rey, California, United States, 90292
        • Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc
      • San Diego, California, United States, 92108
        • Affiliated Research Institute
      • San Francisco, California, United States, 94143
        • University at San Francisco Medical Center
      • Santa Rosa, California, United States, 95405
        • Radiant Research
      • Simi Valley, California, United States, 93065
        • Dr Weintraub James
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The George Washington University Medical Center
    • Florida
      • West Palm Beach, Florida, United States, 33406
        • Visions Clinical Research
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Atlanta Dermatology and Vein Research Center
    • Illinois
      • Lincolnshire, Illinois, United States, 60069
        • SKINQRI
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Welborn Clinic
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Research Group, LLC
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Dolby Research, LLC
    • Michigan
      • Port Huron, Michigan, United States, 48060
        • Hamzavi Dermatology
      • Troy, Michigan, United States, 48084
        • Somerset Skin Clinic
    • Nevada
      • Henderson, Nevada, United States, 89052
        • James Del Rosso, DO - Office of Dr. James Del Russo
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10021
        • Skin Specialty Group
      • Stony Brook, New York, United States, 11790-2598
        • Derm Research Center of NY, Inc.
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Zoe Draelos
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Health Sciences Center - Dept. of Dermatology
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Allergy, Asthma and Dermatology Research Center, LLC
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Radiant Research
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Dermatology Associates of Knoxville
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Center for Dermatology
      • Dallas, Texas, United States, 75390-9190
        • UTSW Medical Center at Dallas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch at Galveston
    • Utah
      • Layton, Utah, United States, 84041
        • Tanner Clinic
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care

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

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A clinical diagnosis of acne vulgaris with facial involvement.
  • A minimum of 20 but not more than 50 Inflammatory lesions
  • A minimum of 30 but not more than 100 Noninflammatory lesions
  • A score of 3 (Moderate) on the Investigator's Global Assessment Scale.

Exclusion Criteria:

  • More than one acne nodule or any acne cyst.
  • Acne conglobata, acne fulminans, secondary acne, or severe acne.
  • Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
  • Underlying diseases that require the use of interfering topical or systemic therapy.
  • Use of prohibited medications prior to the study unless appropriate washout period is documented
  • Use of hormonal contraceptives solely for control of acne

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Adapalene/Benzoyl Peroxide Topical Gel
Drug: Adapalene/Benzoyl Peroxide
Topical Gel, One application daily in the evening for 12 weeks
Active Comparator: 2
Adapalene Topical Gel
Drug: Adapalene
Topical Gel,One application daily in the evening for 12 weeks
Active Comparator: 3
Benzoyl Peroxide Topical Gel
Drug: Benzoyl Peroxide
Topical Gel, one application daily in the evening for 12 weeks
Placebo Comparator: 4
Topical Gel Vehicle
Drug: Topical Gel Vehicle
Topical Gel Vehicle,one application daily in the evening for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate on the Investigator's Global Assessment
Time Frame: at week 12
Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)
at week 12
Changes in Inflammatory Lesion Counts
Time Frame: from Baseline to week 12
Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts
from Baseline to week 12
Changes in Noninflammatory Lesion Counts
Time Frame: from Baseline to week 12
Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count
from Baseline to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Inflammatory Lesion Counts
Time Frame: at week 12
Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
at week 12
Percent Change in Noniflammatory Lesion Counts
Time Frame: at week 12
Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
at week 12
Percent Change in Total Lesion Counts
Time Frame: at week 12
Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
at week 12

Collaborators and Investigators

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

Sponsor

Galderma R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

October 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 11, 2007

First Submitted That Met QC Criteria

January 11, 2007

First Posted (Estimate)

January 15, 2007

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.06.SPR.18088

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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