Topical Ruxolitinib in Chronic Hand Dermatitis (NCT05293717) | Clinical Trial Compass
CompletedPhase 1/2
Topical Ruxolitinib in Chronic Hand Dermatitis
United States16 participantsStarted 2022-07-11
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of chronic hand eczema defined as hand eczema, which has persisted for more than 3 months or returned twice or more within the last 12 months.
* Disease severity graded as moderate to severe according to IGA (i.e., IGA ≥2).
* Recent history (within 1 year before the screening visit) of inadequate response to topical corticosteroid and/or calcineurin inhibitors treatment or topical corticosteroid treatment being medically inadvisable.
Exclusion Criteria:
* Active atopic dermatitis in regions other than the hands requiring medical treatment.
* Active psoriasis in regions other than the hands requiring medical treatment.
* Clinically significant infection (e.g., impetiginized hand eczema or tinea manum) on the hands.
* Patients with excessive contact of hands with water (longer than 2 hours at day; or \> 20 hands washing at day) that is believed to be a predominant cause of the hand dermatitis.
* Subjects with known antigen sensitization based on Patch test (with 3 years) that are unable to reduce contact with the specific antigen(s).
* Subjects chronically and consistently exposed to known-irritant or other substance known to impact skin barrier will be excluded based on PI judgement
* Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 4 weeks prior to baseline.
* Systemic treatment with antibiotics within 4 weeks prior to baseline
* Phototherapy on the hands within 4 weeks prior to ba…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Patients With Chronic Hand Dermatitis Improvement as Assessed by Investigators Global Assessment
Timeframe: week 12
2
Percent Change in Mean Hand Eczema Severity Index (HECSI)