Taro Pharmaceuticals USA Inc.
Hawthorne, New York, 10532, United States
NCT Number: NCT06673654
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
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Notify Me12 year and older
All sexes
Interventional
Phase 1
Hawthorne, New York, 10532, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Test Product
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.
Other names: Reference Product
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.
Other names: Vehicle
Time frame: Baseline to Week 8
The percentage of subjects in each treatment group with "Treatment Success" (defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline, at the Week 8 (Day 56 ± 4 days) visit.
Sun Pharmaceutical Industries, Inc.
Industry
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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