Status:
COMPLETED
Bio-equivalence Study With Clinical Endpoints 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
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Detailed Description
Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Eligibility Criteria
Inclusion
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40years 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 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 adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2020
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT04321070
Start Date
September 9 2019
End Date
March 6 2020
Last Update
April 10 2025
Active Locations (1)
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1
Catawba Research LLC
Charlotte, North Carolina, United States, 28217