Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Completed · Phase 1 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.

Key facts

Study ID: NCT04134273
Run by: Sun Pharmaceutical Industries, Inc.
People needed: 1260
Starts: 2019-03-20
Expected to finish: 2019-10-15
Last updated by the study team: 2019-10-22

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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).

Where it is running

Catawba Research, LLC — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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