To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - 40
Updated:5/20/2018
Start Date:August 21, 2017
End Date:January 26, 2018

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A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.1% to RETIN-A® (TRETINOIN) CREAM, 0.1% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.

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) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris

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.
We found this trial at
1
site
5200 77 Center Drive
Charlotte, North Carolina 28217
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from
Charlotte, NC
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