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

Phase 3

Completed

Interventions: Drug: Adapalene Gel, 0.1%
Drug: Benzoyl Peroxide Gel 2.5%
Drug: Gel Vehicle
Drug: Adapalene/Benzoyl Peroxide

Brief Summary: This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were 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 participant should remain the same during the study.

The primary objective was 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

Not provided

Arm && Interventions

Group	Intervention	Description
Adapalene Gel, 0.1%	Adapalene Gel, 0.1%	Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
Benzoyl Peroxide Gel 2.5%	Benzoyl Peroxide Gel 2.5%	Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
Gel Vehicle	Gel Vehicle	Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
Adapalene/Benzoyl Peroxide Gel	Adapalene/Benzoyl Peroxide	Participants were treated with adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)	At Week 12	Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF.
Change in Inflammatory Lesion Count From Baseline to Week 12	Baseline to Week 12	Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
Change in Noninflammatory Lesion Count From Baseline to Week 12	Baseline to Week 12	Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12	Baseline, Week 12	The Inflammatory Lesion Count was the sum of papules and pustules. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value \* 100. All missing values were imputed by LOCF.
Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12	Baseline, Week 12	The Noninflammatory Lesion Count was the sum of open comedones and closed comedones. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value \* 100. All missing values were imputed by LOCF.
Percent Change From Baseline in Total Lesion Counts at Week 12	Baseline, Week 12	The Total Lesion Count was the sum of Inflammatory, Noninflammatory Lesion Counts, Nodules and Cysts.