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

• Status: Completed
• Trial end date: 2018-01-26
• Target enrollment: 0
• Participant gender: All

Summary

Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Taro Pharmaceuticals USA
• Treatments: Tretinoin

Criteria

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.