A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Trifarotene Cream 0.005%; Drug: AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories); Drug: Placebo

• Registration Number: NCT06063473
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris

Detailed Description

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) to AKLIEF® Cream and both active treatments to a placebo control in the treatment of acne vulgaris

Study Timeline

• Study Start: 2023-02-22
• Primary Completion: 2023-07-13
• Study Completion: 2023-07-13
• Status Verified: 2023-09
• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-27
• Last Update Submitted: 2023-09-27
• Study First Posted: 2023-10-02
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 762

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)
• Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.

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
Trifarotene Cream 0.005%	Trifarotene Cream 0.005%	The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days.
AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)	AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)	The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days.
Placebo Control	Placebo	The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days.

Primary Outcome Measures

Name	Time	Method
Demonstration in Therapeutic Equivalence & Safety of the Investigational Product	Baseline to Week 12	Percent change in the inflammatory (papules and pustules) \& non-inflammatory (open and closed comedones) lesion counts

Trial Locations

Locations (1)

Taro Pharmaceuticals USA Inc.; 🇺🇸 Hawthorne, New York, United States