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

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

Key facts

Study ID

NCT04321070

Run by

Sun Pharmaceutical Industries, Inc.

People needed

550

Starts

2019-09-09

Expected to finish

2020-03-06

Last updated by the study team

2025-04-10

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 ≤ 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).

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 adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.

Where it is running

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

Full record on ClinicalTrials.gov

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