Overview
To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris
Status:
Completed
Completed
Trial end date:
2018-01-26
2018-01-26
Target enrollment:
0
0
Participant gender:
All
All
Summary
Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.Phase:
Early Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Taro Pharmaceuticals USATreatments:
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).
- Subjects must be willing and able to understand and comply with the requirements of
the protocol, including attendance at the required study visits.
Exclusion Criteria:
- Female Subjects who are pregnant, nursing or planning to become pregnant during study
participation.