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

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an investigator-initiated, proof of concept, open study to assess efficacy of a topical Ruxolitinib in subjects with Chronic Hand Dermatitis (CHD). The study will be conducted at the University of Rochester Medical center, Dermatology Department - Rochester, NY. Qualified and enrolled subjects (see Inclusion/Exclusion criteria) will be required to come to URMC Dermatology Clinic for at least five visits.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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