A Study Comparing Tretinoin Gel Microsphere, 0.1% and RETIN-A MICRO ® Gel Microsphere, 0.1% in the Treatment of Acne Vulgaris

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

To demonstrate the therapeutic equivalence and safety of Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

Key facts

Study ID: NCT04883736
Run by: Sun Pharmaceutical Industries, Inc.
People needed: 973
Starts: 2020-08-31
Expected to finish: 2021-04-16
Last updated by the study team: 2021-05-12

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: 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 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)

You may not qualify if…

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).

Where it is running

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

Full record on ClinicalTrials.gov

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