To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.

Key facts

Study ID

NCT03433378

Run by

Sun Pharmaceutical Industries, Inc.

People needed

700

Starts

2017-08-04

Expected to finish

2018-01-26

Last updated by the study team

2018-05-18

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 must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below).

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.

Where it is running

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

Full record on ClinicalTrials.gov

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