To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris
Sponsored by Taro Pharmaceuticals USA
About this trial
Last updated 7 years ago
Study ID
TRTC 1623
Status
Completed
Type
Interventional
Phase
Early Phase 1
Placebo
No
Accepting
12 to 40 Years
All
Trial Timing
Ended 7 years ago
What is this trial about?
Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.
What are the participation requirements?
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.