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

NCT06733402 | Completed Phase 1 FDA Drug

• 1 other identifier: TRFC-2405
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Trifarotene Cream 0.005%

EXPERIMENTAL

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%

AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG

ACTIVE COMPARATOR

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

AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT

ACTIVE COMPARATOR

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

Placebo Control

PLACEBO COMPARATOR

A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.

Drug: Placebo

Interventions

Trifarotene Cream 0.005% DRUG

A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.

Also known as: Test Product

Trifarotene Cream 0.005%

AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG DRUG

A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.

Also known as: Reference Product

AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG

AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT DRUG

A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.

Also known as: Reference Product

AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT

Placebo DRUG

A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.

Also known as: Vehicle

Placebo Control

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, 10532, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

trifarotene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Natalie Yantovskiy

  Taro Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: June 20, 2024
• Primary Completion: June 20, 2024
• Study Completion: November 9, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)