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

Phase 3

Completed

Interventions: Drug: Adapalene/Benzoyl Peroxide
Drug: Topical Gel Vehicle
Drug: Adapalene
Drug: Benzoyl Peroxide

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
1	Adapalene/Benzoyl Peroxide	Adapalene/Benzoyl Peroxide Topical Gel
4	Topical Gel Vehicle	Topical Gel Vehicle
2	Adapalene	Adapalene Topical Gel
3	Benzoyl Peroxide	Benzoyl Peroxide Topical Gel

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percent Change in Inflammatory Lesion Counts	at week 12	Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Percent Change in Noniflammatory Lesion Counts	at week 12	Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Percent Change in Total Lesion Counts	at week 12	Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

Locations (61): Medical Affliated Research Center
🇺🇸
Huntsville, Alabama, United States
Dermatology Research of Arkansas
🇺🇸
Little Rock, Arkansas, United States
Associates in research, Inc.
🇺🇸
Fresno, California, United States
University of California, Irvine
🇺🇸
Irvine, California, 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
Affiliated Research Institute
🇺🇸
San Diego, California, United States
University at San Francisco Medical Center
🇺🇸
San Francisco, California, United States
Radiant Research
🇺🇸
Anderson, South Carolina, United States
Dr Weintraub James
🇺🇸
Simi Valley, California, United States
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Medical Affliated Research Center
🇺🇸Huntsville, Alabama, United States