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

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Placebo; Drug: Trifarotene Cream 0.005%; Drug: AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT; Drug: AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG

Study type: Interventional

Funder types: Industry

Identifiers

NCT06733402

TRFC-2405

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,000 participants in 4 patient groups, including a placebo group

Trifarotene Cream 0.005%

Experimental group

Description:

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

Treatment:

Drug: Trifarotene Cream 0.005%

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

Active Comparator group

Description:

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

Treatment:

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

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

Active Comparator group

Description:

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

Treatment:

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

Placebo Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo