Status:
COMPLETED
A Study Comparing Adapalene Gel 0.1% and to Differin Gel 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
To demonstrate therapeutic equivalence and safety of adapalene gel 0.1% (Taro Pharmaceuticals U.S.A., Inc.) and Differin® Gel (Adapalene Gel 0.1%, Galderma) in the treatment of acne vulgaris.
Detailed Description
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, Adapalene Gel 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and to Differin® Gel (Adapalene 0.1%, Galderma) and both activ...
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)
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 :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2021
Estimated Enrollment :
978 Patients enrolled
Trial Details
Trial ID
NCT04797793
Start Date
May 18 2020
End Date
January 8 2021
Last Update
April 1 2021
Active Locations (1)
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1
Catawba Research, LLC
Charlotte, North Carolina, United States, 28217