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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
Awards & highlights

Study Summary

This trial will assess a cream to treat chronic hand eczema in adults with moderate to severe symptoms.

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.Check my eligibility
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.See study design
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
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I have been diagnosed with chronic hand eczema for at least 6 months.
Select...
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving IGA-CHE-TS
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
365 Previous Clinical Trials
55,003 Total Patients Enrolled
1 Trials studying Hand Eczema
Incyte Medical MonitorStudy DirectorIncyte Corporation
23 Previous Clinical Trials
4,886 Total Patients Enrolled

Media Library

Ruxolitinib cream (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05906628 — Phase 2
Hand Eczema Research Study Groups: Ruxolitinib, Vehicle
Hand Eczema Clinical Trial 2023: Ruxolitinib cream Highlights & Side Effects. Trial Name: NCT05906628 — Phase 2
Ruxolitinib cream (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05906628 — Phase 2
Hand Eczema Patient Testimony for trial: Trial Name: NCT05906628 — Phase 2

Frequently Asked Questions

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

How many healthcare facilities are involved in conducting this research trial?

"The roster of sites for this trial comprise 33 additional centres beyond Dermatology Research Associates in Los Angeles, Well Pharma Medical Research Corporation in Miami, and Forcare Clinical Research in Tampa."

Answered by AI

Is this investigation still accepting participants?

"Affirmative. Clinicaltrials.gov reveals that the trial, which was initially posted on August 14th 2023 is now actively seeking participants. A total of 180 patients are required to be recruited from a pool of 35 sites."

Answered by AI

What is the size of the sample population involved in this research study?

"Yes, as indicated on clinicaltrials.gov this medical trial is seeking participants at the moment. This investigation was first posted on August 14th 2023 and most recently updated July 26th 2023, with a target of 180 enrollees from 35 different sites."

Answered by AI

What potential risks have been identified with taking Ruxolitinib?

"There is minimal clinical evidence supporting the safety of Ruxolitinib, meaning it was assigned a score of 2. The lack of data on efficacy further supports this assessment."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Juva Skin and Laser Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I’ve have had several experiences with breakouts of eczema from toddler to adult age so that’s why I like to share.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Juva Skin and Laser Center: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Topical Ruxolitinib Evaluation in Chronic Hand Eczema
2023. "Topical Ruxolitinib Evaluation in Chronic Hand Eczema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05906628.
All > Seborrheic Dermatitis > Eczema
~46 spots leftby Aug 2024
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