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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 3 weeks

Treatment 8 weeks

Follow Up week 8

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ 3 weeks3 visits

Treatment ~ 8 weeks4 visits

Follow Up ~ week 8

Screening ~ 3 weeks

Treatment ~ 8 weeks

Follow Up ~week 8

This trial's timeline: 3 weeks for screening, 8 weeks for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The percentage of subjects in each treatment group with 'Treatment Success'

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Taro Pharmaceuticals U.S.A, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants still able to apply for enrollment in this ongoing research study?

"Indeed, according to the information available on clinicaltrials.gov, this study is actively seeking eligible participants. The trial was first posted for recruitment on July 18th, 2023 and has been updated most recently on October 18th, 2023."

Answered by AI

What is the current number of individuals eligible for enrollment in this clinical research study?

"Indeed, information available on clinicaltrials.gov indicates that this study is actively recruiting participants. The trial was initially posted on July 18th, 2023 and recently updated on October 18th, 2023. A total of 448 individuals will be enrolled in the study across a single site."

Answered by AI

What are the potential risks and hazards associated with administering Ruxolitinib to patients in the treatment group?

"Given that this trial is classified as Phase 4, indicating approval of the treatment, our team at Power rates the safety of Treatment Group: Ruxolitinib to be a 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ruxolitinib and Opzelura for Atopic Dermatitis

2023. "Ruxolitinib and Opzelura for Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/BDRXCL.

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