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
Overview
- Phase
- Phase 3
- Intervention
- Gel Vehicle
- Conditions
- Acne Vulgaris
- Sponsor
- Galderma R&D
- Enrollment
- 1668
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- Not provided
Arms & Interventions
Gel Vehicle
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
Intervention: Gel Vehicle
Adapalene/Benzoyl Peroxide Gel
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.
Intervention: Adapalene/Benzoyl Peroxide
Adapalene Gel, 0.1%
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
Intervention: Adapalene Gel, 0.1%
Benzoyl Peroxide Gel 2.5%
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
Intervention: Benzoyl Peroxide Gel 2.5%
Outcomes
Primary Outcomes
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)
Time Frame: 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
Time Frame: 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
Time Frame: Baseline to Week 12
Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
Secondary Outcomes
- Percent Change From Baseline in Inflammatory Lesion Counts at Week 12(Baseline, Week 12)
- Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12(Baseline, Week 12)
- Percent Change From Baseline in Total Lesion Counts at Week 12(Baseline, Week 12)