A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT; Drug: Trifarotene Cream 0.005%; Drug: AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG; Drug: Placebo

• Registration Number: NCT06733402
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.

Detailed Description

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and each active treatment to a placebo control in the treatment of acne vulgaris.

Study Timeline

• Study Start: 2024-06-20
• Primary Completion: 2024-06-20
• Study Completion: 2024-11-09
• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 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).
• 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.
• Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.

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 Trifarotene, retinoids and/or any of the study medication ingredients.
• Subjects with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
• Subjects with a baseline irritation score of 3 = severe (marked, intense).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT	AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT	A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
Trifarotene Cream 0.005%	Trifarotene Cream 0.005%	A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG	AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG	A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
Placebo Control	Placebo	A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.

Primary Outcome Measures

Name	Time	Method
Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product	Baseline to Week 12	Percentage change in the inflammatory (papules and pustules) \& non-inflammatory (open and closed comedones) of the lesion counts.

Trial Locations

Locations (1)

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