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

The objectives of this study are to evaluate the therapeutic equivalence and safety of the
test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product
Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne
vulgaris and to demonstrate the superiority of the efficacy of these test and reference
products over the placebo control.

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.