A Study, Comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream for the Treatment of Mild-to-Moderate Atopic Dermatitis.

PHASE1CompletedINTERVENTIONAL
Enrollment

476

Participants

Timeline

Start Date

August 11, 2023

Primary Completion Date

September 23, 2024

Study Completion Date

September 23, 2024

Conditions
Atopic Dermatitis
Interventions
DRUG

Ruxolitinib Topical Cream 1.5%

The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.

DRUG

OPZELURA (Ruxolitinib) Cream

The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.

DRUG

Placebo

The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.

Trial Locations (1)

10532

Taro Pharmaceuticals USA Inc., Hawthorne

All Listed Sponsors
lead

Sun Pharmaceutical Industries, Inc.

INDUSTRY