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
- Adapalene/Benzoyl Peroxide
- Conditions
- Acne Vulgaris
- Sponsor
- Galderma R&D
- Enrollment
- 1670
- Locations
- 61
- Primary Endpoint
- Changes in Noninflammatory Lesion Counts
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
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
- •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
Arms & Interventions
1
Adapalene/Benzoyl Peroxide Topical Gel
Intervention: Adapalene/Benzoyl Peroxide
2
Adapalene Topical Gel
Intervention: Adapalene
3
Benzoyl Peroxide Topical Gel
Intervention: Benzoyl Peroxide
4
Topical Gel Vehicle
Intervention: Topical Gel Vehicle
Outcomes
Primary Outcomes
Changes in Noninflammatory Lesion Counts
Time Frame: 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
Time Frame: at week 12
Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)
Changes in Inflammatory Lesion Counts
Time Frame: from Baseline to week 12
Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts
Secondary Outcomes
- 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)