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

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 (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and Each Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris.

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 1000
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Hawthorne, New York, United States, 10532
      • Taro Pharmaceuticals USA Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Test Product
Active Comparator: 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.	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.; Other Names: Reference Product
Active Comparator: 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.	Drug: 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.; Other Names: Reference Product
Placebo Comparator: Placebo Control; A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.	Drug: Placebo; A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA
• Investigators: Study Director: Natalie Yantovskiy, Taro Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): November 9, 2024

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Estimated): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Dermatologic Agents; Trifarotene
• Other Study ID Numbers: TRFC-2405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes