Status:
COMPLETED
A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-40 years
Phase:
PHASE1
Brief Summary
To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris
Detailed Description
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) to AKLIEF® Cream and both active treatments t...
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 ages 12 to 17 years of age inclusive must have provided IRB approved written assent;
- Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3,or 4 as per the Investigator's Global Assessment (IGA)
- Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.
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 :
February 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2023
Estimated Enrollment :
762 Patients enrolled
Trial Details
Trial ID
NCT06063473
Start Date
February 22 2023
End Date
July 13 2023
Last Update
October 2 2023
Active Locations (1)
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1
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, United States, 10532