A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study are to evaluate the therapeutic equivalence and safety.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taro Pharmaceuticals USA
• Treatments: Benzoyl Peroxide; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Criteria

Inclusion Criteria:

• Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.

• Must have a minimum ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.

• Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion Criteria:

• Female subjects who are pregnant, nursing or planning to become pregnant during study participation.

• A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.

• A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.