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 range18 Years – 75 Years
SexALL
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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…
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)