Topical Ruxolitinib for Hand Eczema
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to test the effectiveness of a cream called Ruxolitinib for individuals with chronic hand eczema (persistent or frequently recurring hand rash). Participants will apply the cream to their hands twice daily to assess its impact on their condition. The study seeks individuals whose hand eczema has persisted for over three months or has recurred multiple times in the past year, particularly if previous treatments like steroid creams have been ineffective or unsuitable. As a Phase 1/Phase 2 trial, the research focuses on understanding the treatment's mechanism and measuring its effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
Yes, you may need to stop certain medications. The trial requires that you stop using systemic immunosuppressive drugs, antibiotics, and certain topical treatments on your hands for a specific period before starting the trial. Check with the trial team for details on your specific medications.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that ruxolitinib cream is usually safe for skin application. Studies have found that it rarely causes serious side effects, with most participants experiencing no major issues. Common side effects included mild redness or itching at the application site.
The FDA has approved ruxolitinib cream for treating atopic dermatitis (a type of eczema), confirming its safety for skin use. However, avoid applying the cream to sensitive areas such as the eyes, mouth, or private parts.
Prospective clinical trial participants should consult their doctor for more information about what to expect and how to use the treatment safely.12345Why do researchers think this study treatment might be promising?
Unlike traditional treatments for hand eczema, which often involve steroids or emollients, Ruxolitinib cream is a topical medication that targets the JAK-STAT pathway, a key player in the inflammatory process. This novel mechanism of action helps reduce inflammation directly at the source. Researchers are excited about Ruxolitinib because it offers a targeted approach, potentially reducing side effects associated with systemic treatments and providing relief more quickly and effectively for those struggling with persistent eczema.
What evidence suggests that topical Ruxolitinib might be an effective treatment for hand eczema?
Research has shown that ruxolitinib cream can help treat chronic hand eczema. In one study, over half of the patients (53.2%) achieved clear or almost clear skin after using the cream. Patients also experienced less skin pain and an improved quality of life. The cream was well tolerated, causing no new or unexpected side effects. These findings suggest that ruxolitinib cream could be a promising option for managing hand eczema symptoms.36789
Are You a Good Fit for This Trial?
This trial is for adults with Chronic Hand Dermatitis (CHD) who haven't responded well to standard creams or can't use them. They should have had CHD for more than 3 months or recurring episodes over the past year. People can't join if they've used certain skin treatments recently, are pregnant/breastfeeding, have unstable health conditions, a history of skin cancer on hands within 5 years, HIV, excessive hand washing, or known allergies to substances they can't avoid.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants apply Ruxolitinib cream to their skin at home twice daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ruxolitinib
Trial Overview
The study tests Ruxolitinib cream's effectiveness in treating CHD at the University of Rochester Medical Center. Participants will visit the clinic five times and must meet specific criteria including having moderate to severe CHD despite previous treatments.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
You are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily.
Ruxolitinib is already approved in United States, European Union for the following indications:
- Intermediate or high-risk myelofibrosis
- Polycythemia vera
- Steroid-refractory acute graft-versus-host disease
- Chronic graft-versus-host disease
- Vitiligo
- Intermediate or high-risk myelofibrosis
- Polycythemia vera
- Steroid-refractory acute graft-versus-host disease
- Chronic graft-versus-host disease
- Non-segmental vitiligo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Citations
Efficacy and safety of ruxolitinib cream for the treatment ...
In this first randomized controlled trial of ruxolitinib cream in chronic, nonatopic hand eczema, most (53.2%) patients achieved clear/almost ...
Efficacy and safety of ruxolitinib cream for the treatment ...
Improvements in skin pain and quality of life were reported during the study. Ruxolitinib cream was well tolerated, with no new safety signals ...
Efficacy and Safety of Ruxolitinib Cream for the Treatment ...
Improvements in skin pain and quality of life were reported during the study. Ruxolitinib cream was well tolerated, with no new safety signals ...
4.
incytemi.com
incytemi.com/document/Poster/Fall%20Clinical%202025_Stein%20Gold%20LF_Phase%202%20Rux%20Cream%20CHE%2032-Week%20Data.pdfEfficacy and Safety of Ruxolitinib Cream for the Treatment ...
In patients with nonatopic CHE, 1.5% ruxolitinib cream. BID substantially improved clinical signs, symptoms,.
NCT05293717 | Topical Ruxolitinib in Chronic Hand ...
This is an investigator-initiated, proof of concept, open study to assess efficacy of a topical Ruxolitinib in subjects with Chronic Hand Dermatitis (CHD).
OPZELURA® (ruxolitinib) cream, for topical use
The safety and effectiveness of OPZELURA have not been established in pediatric patients younger than 2 years of age with atopic dermatitis. Nonsegmental ...
Mild to Moderate Atopic Dermatitis
IMPORTANT SAFETY INFORMATION. OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina. OPZELURA may cause serious side effects, ...
8.
mayoclinic.org
mayoclinic.org/drugs-supplements/ruxolitinib-topical-application-route/description/drg-20523259Ruxolitinib (topical application route) - Side effects & dosage
Ruxolitinib topical is used to treat mild to moderate atopic dermatitis (eczema) in non-immunocompromised patients whose condition is not well controlled with ...
Ruxolitinib (Opzelura) - NCBI Bookshelf
The sponsor notes that CDA-AMC acknowledged the long-term safety data that exist for ruxolitinib 1.5% cream but did not consider it, citing it was out of scope.
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