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Janus Kinase (JAK) Inhibitor

Treatment Group: Ruxolitinib for Atopic Dermatitis

Verified Trial
Phase 4
Recruiting
Research Sponsored by Taro Pharmaceuticals U.S.A, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Do you have at least 3 handprints of Eczema on your body?
Is your Eczema more moderate to severe ?
Must not have
Are you currently pregnant, nursing, or planning a pregnancy?
Timeline
Screening 0 days
Treatment 8 weeks
Follow Up 0 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to compare the effectiveness and safety of two creams, Ruxolitinib Topical Cream 1.5% and OPZELURA (Ruxolitinib Cream), in

Who is the study for?
This trial is for individuals with mild-to-moderate atopic dermatitis, commonly known as eczema. Participants should have a diagnosis of this skin condition to be eligible.
What is being tested?
The study aims to compare the effectiveness and safety of two creams: Ruxolitinib cream 1.5% by Taro Pharmaceuticals and Opzelura cream 1.5%, both intended for atopic dermatitis treatment.
What are the potential side effects?
Potential side effects may include skin irritation, redness, itching or burning sensation where the cream is applied. More serious side effects are less common but could involve changes in immune system function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 0 days
Treatment ~ 8 weeks
Follow Up ~0 days
This trial's timeline: 0 days for screening, 8 weeks for treatment, and 0 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The percentage of subjects in each treatment group with 'Treatment Success'

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment Group: RuxolitinibExperimental Treatment1 Intervention
Ruxolitinib cream 1.5% is to be self-administered by applying as a thin layer twice daily to cover the affected areas up to 20% body surface area approximately 8 weeks.
Group II: Treatment Group: OpzeluraExperimental Treatment1 Intervention
Opzelura cream 1.5% is to be self-administered by applying as a thin layer twice daily to cover the affected areas up to 20% body surface area approximately 8 weeks.
Group III: PlaceboExperimental Treatment0 Interventions
Placebo is to be self-administered by applying as a thin layer twice daily to cover the affected areas up to 20% body surface area approximately 8 weeks.

Find a Location

Who is running the clinical trial?

Taro Pharmaceuticals U.S.A, Inc.Lead Sponsor
~192 spots leftby Nov 2025
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