A Long-term Safety and Efficacy Study of a Fixed Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% (Adapalene and Benzoyl Peroxide Topical Gel) Gel in Subjects With Acne Vulgaris

RD.06.SPR.18089

This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel. Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12. Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.

2004-02-17

2005-05-23

2005-05-23

Completed

Early phase I

452

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. Exclusion Criteria: * Subjects with presence of nodules or cysts. * Acne conglobate, acne fulminans, secondary acne, or severe acne. * Underlying diseases that required the use of interfering topical or systemic therapy. * Use of prohibited medications prior to the study unless appropriate washout period was documented.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 452, 'type': 'ACTUAL'}}

2023-07-11