Status:
COMPLETED
To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-40 years
Phase:
EARLY_PHASE1
Brief Summary
Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.
Detailed Description
A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (VALEANT) an...
Eligibility Criteria
Inclusion
- 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
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
Key Trial Info
Start Date :
August 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2018
Estimated Enrollment :
455 Patients enrolled
Trial Details
Trial ID
NCT03427554
Start Date
August 21 2017
End Date
January 26 2018
Last Update
May 18 2018
Active Locations (1)
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1
Catawba Research, LLC
Charlotte, North Carolina, United States, 28217