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

• Sponsor: Taro Pharmaceuticals USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06063473
• Collaborator: (none)
• Enrollment: 762
• Location: 1
• Arms: 3
• Actual Duration (Months): 4.6
• Patients Per Site Per Month: 164.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Trifarotene Cream 0.005%; Drug: Placebo; Drug: AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 762 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) and to AKLIEF® Cream (Trifarotene 0.005%,Galderma) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
• Actual Study Start Date: Feb 22, 2023
• Actual Primary Completion Date: Jul 13, 2023
• Actual Study Completion Date: Jul 13, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Trifarotene Cream 0.005%; 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; Other Names: Test Product
Active Comparator: 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.	Drug: AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories); 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; Other Names: Reference Product
Placebo Comparator: Placebo Control 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.	Drug: Placebo; 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; Other Names: Vehicle

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taro Pharmaceuticals USA Inc.	Hawthorne	New York	United States	10532

Sponsors and Collaborators

• Taro Pharmaceuticals USA

Investigators

• Study Director: Natalie Yantovskiy, Taro Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taro Pharmaceuticals USA
• ClinicalTrials.gov Identifier: NCT06063473
• Other Study ID Numbers: TRFC-2208
• First Posted: Oct 2, 2023
• Last Update Posted: Oct 2, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Acne Vulgaris; Trifarotene

Study Results

No Results Posted as of Oct 2, 2023