Topical Ruxolitinib for Hand Eczema

Overseen By Karen Clark

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Rochester

Must not be taking: Immunosuppressives, Retinoids, Corticosteroids, others

Disqualifiers: Atopic dermatitis, Psoriasis, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

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. ^{1 2 3 4 5}

Why 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. ^{3 6 7 8 9}

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

My condition is considered moderate to severe.

I have had hand eczema for over 3 months or it has come back twice in the last year.

Topical treatments haven't worked for me in the past year, or I can't use them for health reasons.

Exclusion Criteria

I have had skin cancer on my hands in the last 5 years.

I haven't used any antibiotic creams on my hands in the last 2 weeks.

I am not pregnant, breastfeeding, or planning to become pregnant during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply Ruxolitinib cream to their skin at home twice daily for 12 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

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?

Group I: All Participants Experimental Treatment 1 Intervention

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:

Approved in United States as Jakafi for:

• Intermediate or high-risk myelofibrosis
• Polycythemia vera
• Steroid-refractory acute graft-versus-host disease
• Chronic graft-versus-host disease
• Vitiligo

Approved in European Union as Jakavi for:

• Intermediate or high-risk myelofibrosis
• Polycythemia vera
• Steroid-refractory acute graft-versus-host disease
• Chronic graft-versus-host disease
• Non-segmental vitiligo

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Incyte Corporation

Industry Sponsor

Trials

408

Recruited

66,800+

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

1. jaad.org jaad.org/article/S0190-9622(25)02717-3/fulltext

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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40889714/

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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962225027173

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.pdf

Efficacy and Safety of Ruxolitinib Cream for the Treatment ... In patients with nonatopic CHE, 1.5% ruxolitinib cream. BID substantially improved clinical signs, symptoms,.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05293717

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).

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/215309s007lbl.pdf

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 ...

7. opzelura.com opzelura.com/atopic-dermatitis/

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-20523259

Ruxolitinib (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 ...

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK616193

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.