A Study Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% in the Treatment of Acne Vulgaris

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% in the Treatment of Acne Vulgaris

The bioequivalence and safety of Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A® (Tretinoin) Cream 0.025% in the treatment of acne vulgaris.

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A) and RETIN-A® (Tretinoin) Cream 0.025% and Both Active Treatment 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 who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent
• Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA)

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.
• Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).