A Study Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% in the Treatment of Acne Vulgaris

Early Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Tretinoin Cream 0.025%

• Registration Number: NCT04724473
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

The bioequivalence and safety of Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A® (Tretinoin) Cream 0.025% in the treatment of acne vulgaris.

Detailed Description

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A) and RETIN-A® (Tretinoin) Cream 0.025% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris

Study Timeline

• Study Start: 2019-12-10
• Primary Completion: 2020-11-21
• Study Completion: 2020-11-21
• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-26
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1030

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 12 to 17 years of age, inclusive, must have provided IRB approved written assent
• Subjects must have a definite clinical diagnosis of acne vulgaris 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Control	Tretinoin Cream 0.025%	The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Tretinoin Cream 0.025%	Tretinoin Cream 0.025%	The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
RETIN-A® (Tretinoin) Cream 0.025%	Tretinoin Cream 0.025%	The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.

Primary Outcome Measures

Name	Time	Method
Demonstration of Bioequivalence	Baseline to Week 12	To evaluate the percentage change in the inflammatory and non-inflammatory lesion counts

Trial Locations

Locations (1)

Catawba Research, LLC; 🇺🇸 Charlotte, North Carolina, United States