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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421993
• Other study ID #: RD.06.SPR.18088
• Status: Completed
• Phase: Phase 3
• Start date: October 2006
• Est. completion date: December 2007

Study information

• Verified date: October 2009
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1670
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Adapalene/Benzoyl Peroxide
Topical Gel, One application daily in the evening for 12 weeks
• Adapalene
Topical Gel,One application daily in the evening for 12 weeks
• Benzoyl Peroxide
Topical Gel, one application daily in the evening for 12 weeks
• Topical Gel Vehicle
Topical Gel Vehicle,one application daily in the evening for 12 weeks

Locations

Country	Name	City	State
Canada	Ultranova Skin care	Barrie	Ontario
Canada	The Dermatology Centre	Calgary	Alberta
Canada	Stratica Medical	Edmonton	Alberta
Canada	Innovaderm Research Laval Inc.	Laval	Quebec
Canada	Lynderm Research inc.	Markham	Ontario
Canada	Innovaderm Research Inc	Montreal	Quebec
Canada	Siena Medical Research	Montreal	Quebec
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	NewLab Clinical Research	St. John's	Newfoundland and Labrador
Canada	Nexus clinical research	St. John's	Newfoundland and Labrador
Canada	Guildford Dermatology Specialists	Surrey	British Columbia
Canada	Derm Research @ 888 Inc.	Vancouver	British Columbia
Canada	XLR8 Medical Research Inc.	Windsor	Ontario
Canada	Dermadvances Research	Winnipeg	Manitoba
Canada	Winnipeg Clinic	Winnipeg	Manitoba
Germany	Licca Clinical Research Institute	Augsburg
Germany	Henrik Pres	Berlin
Germany	Meike Schroeder	Berlin
Germany	Beatrice Gerlach	Dresden
Germany	Kloverkorn, Windfried	Gilching
Germany	Otto-Von-Guericke-Universitat Magdeburg	Magdeburg
Germany	Michael Sebastian	Mahlow
Germany	Thomas Dirschka	Wuppertal
Hungary	Margit Simola	Budapest
Hungary	Outpatient Dermatilogy Department XIX District	Budapest
Hungary	Outpatient Dermatology Department DUH	Budapest
Poland	Waldemar Placek	Bydgoszcz
Poland	DERMED Specjalistyczne Gabinety Lekarskie	Lodz
Poland	Wojceiech Silny	Poznan
United States	Atlanta Dermatology and Vein Research Center	Alpharetta	Georgia
United States	Radiant Research	Anderson	South Carolina
United States	Arlington Center for Dermatology	Arlington	Texas
United States	Dolby Research, LLC	Baton Rouge	Louisiana
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	UTSW Medical Center at Dallas	Dallas	Texas
United States	Welborn Clinic	Evansville	Indiana
United States	Associates in research, Inc.	Fresno	California
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	James Del Rosso, DO - Office of Dr. James Del Russo	Henderson	Nevada
United States	Zoe Draelos	High Point	North Carolina
United States	Medical Affliated Research Center	Huntsville	Alabama
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	University of California, Irvine	Irvine	California
United States	Dermatology Associates of Knoxville	Knoxville	Tennessee
United States	Allergy, Asthma and Dermatology Research Center, LLC	Lake Oswego	Oregon
United States	Tanner Clinic	Layton	Utah
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	SKINQRI	Lincolnshire	Illinois
United States	Dermatology Research of Arkansas	Little Rock	Arkansas
United States	Dermatology Research Associates	Los Angeles	California
United States	Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc	Marina Del Rey	California
United States	Skin Specialty Group	New York	New York
United States	OU Health Sciences Center - Dept. of Dermatology	Oklahoma City	Oklahoma
United States	Hamzavi Dermatology	Port Huron	Michigan
United States	Affiliated Research Institute	San Diego	California
United States	University at San Francisco Medical Center	San Francisco	California
United States	Radiant Research	Santa Rosa	California
United States	Dr Weintraub James	Simi Valley	California
United States	Derm Research Center of NY, Inc.	Stony Brook	New York
United States	Somerset Skin Clinic	Troy	Michigan
United States	The George Washington University Medical Center	Washington	District of Columbia
United States	Visions Clinical Research	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Hungary,  Poland, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Percent Change in Inflammatory Lesion Counts	Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100	at week 12
Secondary	Percent Change in Noniflammatory Lesion Counts	Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100	at week 12
Secondary	Percent Change in Total Lesion Counts	Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100	at week 12

External Links

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