NCT06733402View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

June 20, 2024

Primary Completion Date

June 20, 2024

Study Completion Date

November 9, 2024

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.

Trial Locations (1)

10532

Taro Pharmaceuticals USA Inc., Hawthorne

All Listed Sponsors
lead

Sun Pharmaceutical Industries, Inc.

INDUSTRY

NCT06733402 - 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 | Biotech Hunter | Biotech Hunter