NCT06673654

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.

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, Comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream and Both Active Treatments to a Placebo Control in the Treatment of Mild-to-Moderate Atopic Dermatitis.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 476 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

To demonstrate the therapeutic equivalence and safety of Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) and OPZELURA (Ruxolitinib) Cream in the treatment of mild-to-moderate atopic dermatitis

Detailed description

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream and both active treatments to a placebo control in the treatment of mild-to-moderate atopic dermatitis.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-11
• Primary completion: 2024-09-23
• Completion: 2024-09-23
• First posted: 2024-11-05
• Last updated: 2024-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study