Status:
COMPLETED
A Study Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% 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
The bioequivalence and safety of Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A® (Tretinoin) Cream 0.025% in the treatment of acne vulgaris.
Detailed Description
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A) and RETIN-A® (Tretinoin) Cream 0.025% and Both Active ...
Eligibility Criteria
Inclusion
- Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA)
Exclusion
- 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.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
Key Trial Info
Start Date :
December 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2020
Estimated Enrollment :
1030 Patients enrolled
Trial Details
Trial ID
NCT04724473
Start Date
December 10 2019
End Date
November 21 2020
Last Update
April 1 2021
Active Locations (1)
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1
Catawba Research, LLC
Charlotte, North Carolina, United States, 28217