What side effects are associated with this type of intervention?

Common treatments for hand eczema include topical corticosteroids, calcineurin inhibitors (like tacrolimus and pimecrolimus), and Janus Kinase (JAK) inhibitors (such as Ruxolitinib). Topical corticosteroids can cause skin thinning, stretch marks, and increased risk of skin infections. Calcineurin inhibitors may lead to burning sensations, especially early in treatment, and have been associated with a potential increased risk of lymphoma and skin cancer. JAK inhibitors, including Ruxolitinib, can cause side effects such as nasopharyngitis, headache, and in some cases, serious infections, cardiovascular events, and increased risk of certain cancers. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

As of now, there is limited information on FDA approvals specifically for the treatment of hand eczema using Janus Kinase (JAK) inhibitors like Ruxolitinib Cream. However, JAK inhibitors have been studied and used in the treatment of other inflammatory skin conditions, such as atopic dermatitis. For instance, topical treatments like tacrolimus and pimecrolimus, which are calcineurin inhibitors, have been approved for eczema and may offer some insights into the potential efficacy of JAK inhibitors for hand eczema. Further studies and clinical trials, such as the one evaluating Ruxolitinib Cream, are necessary to establish their safety and efficacy for this specific condition.

What other types of research exist?

Promising novel alternatives to Ruxolitinib Cream for hand eczema patients include Dupilumab, a monoclonal antibody targeting IL-4 and IL-13, and Narrowband UVB phototherapy, which has shown efficacy in children and could be considered for adults. Additionally, topical calcineurin inhibitors like Tacrolimus and Pimecrolimus may offer benefits, especially in cases where corticosteroids are not effective.

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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Hand Eczema

Phase 2

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CHE for at least 6 months prior to screening. Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares within the previous 12 months.

Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 32, followed by 30 days follow-up

Summary

This trial is testing a cream called ruxolitinib for adults with chronic hand eczema that is moderate to severe. The cream works by blocking enzymes that cause inflammation, which may help reduce eczema symptoms. The goal is to see if this treatment is safe and effective for these patients.

Who is the study for?

Adults with chronic hand eczema (CHE) for at least 6 months, experiencing moderate to severe symptoms. Participants must have had previous CHE treatments or been advised against them and agree to prevent pregnancy or fathering children during the trial. Those with known CHE triggers that can't be avoided, serious health conditions, abnormal lab values, recent use of excluded treatments, or UV therapy on hands are not eligible.

What is being tested?

The study is testing Ruxolitinib cream's effectiveness and safety compared to a placebo (vehicle) in adults with chronic hand eczema. The goal is to see if this cream can reduce the severity of their skin condition.

What are the potential side effects?

Possible side effects of Ruxolitinib cream may include application site reactions like redness or irritation, headaches, increased risk of infections due to immune system effects, and potentially other unknown risks associated with new topical medications.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with chronic hand eczema for at least 6 months.

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I have been treated with at least one prescription chemotherapy, or it was not recommended for me.

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I have had hand eczema for more than 3 months or at least 2 flares in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 32, followed by 30 days follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 32, followed by 30 days follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 32, followed by 30 days follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants achieving IGA-CHE-TS

Secondary study objectives

Change from baseline in CHE-related Itch NRS score

Change from baseline in CHE-related Skin Pain NRS score

Change from baseline in DLQI score

+12 more

Side effects data

From 2021 Phase 3 trial • 330 Patients • NCT04052425

Tibia fracture

100%

80%

60%

40%

20%

Study treatment Arm

Vehicle Cream BID

Ruxolitinib Cream 1.5% BID

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RuxolitinibExperimental Treatment1 Intervention

Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.

Group II: VehiclePlacebo Group1 Intervention

Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib cream

2022

Completed Phase 3

~1850

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for hand eczema include topical corticosteroids, tacrolimus ointment, and JAK inhibitors like Ruxolitinib Cream. Topical corticosteroids reduce inflammation by suppressing the immune response, which helps to alleviate symptoms such as redness, swelling, and itching. Tacrolimus ointment, an immunomodulator, inhibits T-cell activation, thereby reducing inflammation and immune-mediated skin damage. JAK inhibitors like Ruxolitinib block the Janus kinase pathways involved in the inflammatory process, leading to decreased cytokine production and reduced inflammation. These treatments are crucial for hand eczema patients as they target the underlying inflammatory mechanisms, providing relief from symptoms and improving skin condition.

An open-label pilot study to evaluate the safety and efficacy of topically applied tacrolimus ointment for the treatment of hand and/or foot eczema.