NCT05293717

Topical Ruxolitinib in Chronic Hand Dermatitis

Completed Phase 1, PHASE2 Results posted Last updated 25 February 2025

What this trial tests

Phase 1, PHASE2 trial testing Ruxolitinib in Chronic Hand Dermatitis in 16 participants. Completed in 31 December 2024.

Timeline

11 July 2022

Primary endpoint
21 June 2023

31 December 2024

Quick facts

Lead sponsor	University of Rochester
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	11 July 2022
Primary completion	21 June 2023
Estimated completion	31 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Ruxolitinib (RUXOLITINIB) — full drug profile →

Conditions studied

• Chronic Hand Dermatitis — all drugs for Chronic Hand Dermatitis →

Sponsor

University of Rochester

Who can join

Adults 18 to 75, any sex, with Chronic Hand Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Patients With Chronic Hand Dermatitis Improvement as Assessed by Investigators Global Assessment Primary · week 12

Proportion of patients achieving an Investigators Global Assessment (IGA) score of 0 or 1 with at least a 2-step improvement (IGA treatment success). The Investigator Global Assessment (IGA) will provide information of the overall disease. It is a 5-point scale: clear-1, almost clear-2, mild-3, moderate-4, and severe-5.

Group	Value	95% CI
All Participants	0.53

Percent Change in Mean Hand Eczema Severity Index (HECSI) Primary · baseline to week 12

Hand Eczema Severity Index (HECSI) , a well-accepted and validated scoring system for disease activity. It incorporates both the extent and the intensity of the disease. Each hand is divided into five areas: fingertips, fingers (except the tips), palms, back of hands and wrists. Each area will be scored for extension and intensity of the six following clinical signs: erythema, induration /papulation, vesicles, fissuring, scaling, and edema; which are graded on the following scale: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe. Data will be reported as a percent change in the H

Group	Value	95% CI
All Participants	-86.2	± 3.72

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Participants

Serious: 1/16 (6%)

Deaths: 0/16

Serious adverse events (1 terms)

Reaction	System	All Participants
kidney stone	Renal and urinary disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	All Participants
Upper Respiratory Infection	Infections and infestations	—
scalp abscess	Infections and infestations	—

Most-reported serious reactions: kidney stone.

Data from ClinicalTrials.gov NCT05293717 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. New Perspectives in the Management of Chronic Hand Eczema: Lessons from Pathogenesis.
   Tancredi V, Buononato D, Caccavale S, Di Brizzi EV, et al · · 2023 · cited 9× · PMID 38203533 · DOI 10.3390/ijms25010362