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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

NCT06733402 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2024-12-13

No results posted yet for this study

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

Interventions

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.

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.

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Natalie Yantovskiy · Taro Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2024-06-20
Completion
2024-11-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06733402 on ClinicalTrials.gov