Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Test Gel, 5% to ACZONE Gel, 5% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris

Therapeutic equivalence and safety study

To evaluate the therapeutic equivalence and safety of Test formulation and marketed Reference Listed Drug (RLD).

To demonstrate the superiority of efficacy of the Test and Reference products over the placebo control in the treatment.

To compare the safety of Test, Reference and Placebo treatments.

Inclusion Criteria:

• Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris
• Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below)

Exclusion Criteria:

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