To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris

A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing
TRETINOIN CREAM, 0.05% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM,
0.05% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne
Vulgaris

Inclusion Criteria:

- Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years 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

- Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any
of the study medication ingredients.