Overview

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.