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

NCT00421993 | Completed Phase 3 Results

• 1 other identifier: RD.06.SPR.18088
• Study Type: interventional
• Target: 1,670
• Locations: 5 countries
• Sites: 62

Brief Summary

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.

Conditions

Acne Vulgaris

Keywords

Acne vulgaris; Adapalene; Benzoyl Peroxide

Outcome Measures

Primary Outcomes (3)

• Success Rate on the Investigator's Global Assessment

  Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)

  at week 12

• Changes in Inflammatory Lesion Counts

  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

  Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count

  from Baseline to week 12

Secondary Outcomes (3)

• Percent Change in Inflammatory Lesion Counts

  at week 12

• Percent Change in Noniflammatory Lesion Counts

  at week 12

• Percent Change in Total Lesion Counts

  at week 12

Study Arms (4)

1

EXPERIMENTAL

Adapalene/Benzoyl Peroxide Topical Gel

Drug: Adapalene/Benzoyl Peroxide

2

ACTIVE COMPARATOR

Adapalene Topical Gel

Drug: Adapalene

3

ACTIVE COMPARATOR

Benzoyl Peroxide Topical Gel

Drug: Benzoyl Peroxide

4

PLACEBO COMPARATOR

Topical Gel Vehicle

Drug: Topical Gel Vehicle

Interventions

Adapalene/Benzoyl Peroxide DRUG

Topical Gel, One application daily in the evening for 12 weeks

1

Adapalene DRUG

Topical Gel,One application daily in the evening for 12 weeks

2

Benzoyl Peroxide DRUG

Topical Gel, one application daily in the evening for 12 weeks

3

Topical Gel Vehicle DRUG

Topical Gel Vehicle,one application daily in the evening for 12 weeks

4

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (62)

Medical Affliated Research Center

Huntsville, Alabama, 35801, United States

Location

Dermatology Research of Arkansas

Little Rock, Arkansas, 72205, United States

Location

Associates in research, Inc.

Fresno, California, 93720, United States

Location

University of California, Irvine

Irvine, California, 92697-1385, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc

Marina del Rey, California, 90292, United States

Location

Affiliated Research Institute

San Diego, California, 92108, United States

Location

University at San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Radiant Research

Santa Rosa, California, 95405, United States

Location

Dr Weintraub James

Simi Valley, California, 93065, United States

Location

The George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Visions Clinical Research

West Palm Beach, Florida, 33406, United States

Location

Atlanta Dermatology and Vein Research Center

Alpharetta, Georgia, 30005, United States

Location

SKINQRI

Lincolnshire, Illinois, 60069, United States

Location

Welborn Clinic

Evansville, Indiana, 47713, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Dolby Research, LLC

Baton Rouge, Louisiana, 70809, United States

Location

Hamzavi Dermatology

Port Huron, Michigan, 48060, United States

Location

Somerset Skin Clinic

Troy, Michigan, 48084, United States

Location

James Del Rosso, DO - Office of Dr. James Del Russo

Henderson, Nevada, 89052, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Skin Specialty Group

New York, New York, 10021, United States

Location

Derm Research Center of NY, Inc.

Stony Brook, New York, 11790-2598, United States

Location

Zoe Draelos

High Point, North Carolina, 27262, United States

Location

OU Health Sciences Center - Dept. of Dermatology

Oklahoma City, Oklahoma, 73104, United States

Location

Allergy, Asthma and Dermatology Research Center, LLC

Lake Oswego, Oregon, 97035, United States

Location

Radiant Research

Anderson, South Carolina, 29621, United States

Location

Dermatology Associates of Knoxville

Knoxville, Tennessee, 37934, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

UTSW Medical Center at Dallas

Dallas, Texas, 75390-9190, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

The Dermatology Centre

Calgary, Alberta, T2S 3B3, Canada

Location

Stratica Medical

Edmonton, Alberta, T5K 1X3, Canada

Location

Guildford Dermatology Specialists

Surrey, British Columbia, BC V3R 6A7, Canada

Location

Derm Research @ 888 Inc.

Vancouver, British Columbia, V5Z 3Y1, Canada

Location

Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Dermadvances Research

Winnipeg, Manitoba, R3C 1R4, Canada

Location

Nexus clinical research

St. John's, Newfoundland and Labrador, A1B 3E1, Canada

Location

NewLab Clinical Research

St. John's, Newfoundland and Labrador, A1B 4S8, Canada

Location

Ultranova Skin care

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

XLR8 Medical Research Inc.

Windsor, Ontario, N8W 1E6, Canada

Location

Innovaderm Research Laval Inc.

Laval, Quebec, H7S 2C6, Canada

Location

Innovaderm Research Inc

Montreal, Quebec, H2K 4L5, Canada

Location

Siena Medical Research

Montreal, Quebec, H3G1C6, Canada

Location

Licca Clinical Research Institute

Augsburg, 86179, Germany

Location

Henrik Pres

Berlin, 10435, Germany

Location

Meike Schroeder

Berlin, 14169, Germany

Location

Beatrice Gerlach

Dresden, 01097, Germany

Location

Kloverkorn, Windfried

Gilching, 82205, Germany

Location

Otto-Von-Guericke-Universitat Magdeburg

Magdeburg, 39120, Germany

Location

Michael Sebastian

Mahlow, 15831, Germany

Location

Thomas Dirschka

Wuppertal, 42275, Germany

Location

Outpatient Dermatology Department DUH

Budapest, 1036, Hungary

Location

Margit Simola

Budapest, 1084, Hungary

Location

Outpatient Dermatilogy Department XIX District

Budapest, 1195, Hungary

Location

Waldemar Placek

Bydgoszcz, 85096, Poland

Location

DERMED Specjalistyczne Gabinety Lekarskie

Lodz, 90265, Poland

Location

Wojceiech Silny

Poznan, 60355, Poland

Location

Related Publications (1)

• Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x.

  PMID: 12963896 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene, Benzoyl Peroxide Drug Combination; Adapalene; Benzoyl Peroxide; Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Colloids; Complex Mixtures; Dosage Forms

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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: January 15, 2007
• Study Start: October 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 18, 2021
• Results First Posted: March 11, 2009

Record last verified: 2009-10

Locations

DE (8); HU (3); US (33); CA (15); PL (3)