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
This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.
Detailed Description
The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and ...
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; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
- 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 known hypersensitivity to clindamycin or lincomycin and/or any ingredients in the study drugs.
- 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 :
March 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2019
Estimated Enrollment :
1260 Patients enrolled
Trial Details
Trial ID
NCT04134273
Start Date
March 20 2019
End Date
October 15 2019
Last Update
October 22 2019
Active Locations (1)
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1
Catawba Research, LLC
Charlotte, North Carolina, United States, 28217