Overview

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

Status:
Completed
Trial end date:
2021-04-16
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Taro Pharmaceuticals USA
Treatments:
Tretinoin
Criteria
Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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).