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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

NCT ID: NCT06733402

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2024-11-09

Brief Summary

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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

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Trifarotene Cream 0.005%

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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 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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Test Product Reference Product Reference Product Vehicle

Eligibility Criteria

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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).
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Yantovskiy

Role: STUDY_DIRECTOR

Taro Pharmaceuticals, Inc.

Locations

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Taro Pharmaceuticals USA Inc.

Hawthorne, New York, United States

Site Status

Countries

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United States

Other Identifiers

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TRFC-2405

Identifier Type: -

Identifier Source: org_study_id