Topical Ruxolitinib in Chronic Hand Dermatitis

NCT05293717 | Completed Phase 1 Results FDA Drug

• 1 other identifier: STUDY00006638
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hand Dermatitis

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients With Chronic Hand Dermatitis Improvement as Assessed by Investigators Global Assessment

  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.

  week 12

• Percent Change in Mean Hand Eczema Severity Index (HECSI)

  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 HECSI score from baseline to week 12. The score ranges from 0-360.

  baseline to week 12

Study Arms (1)

All Participants

EXPERIMENTAL

You are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily.

Drug: Ruxolitinib

Interventions

Ruxolitinib DRUG

1.5% Ruxolitinib cream

All Participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 baseline.
• Use of topical immunomodulators (e.g., phosphodiesterase-4 (PDE-4) inhibitors, pimecrolimus, tacrolimus) or topical corticosteroids on the hands within 2 weeks prior to baseline.
• Use of topical antibiotics on the hands within 2 weeks prior to baseline.
• Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e., subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
• Other topicals applied therapy on the hands (except for the use of subject's own emollients) within 1 week prior to baseline.
• Receipt of any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline
• Any disorder which is not stable and in the investigator's opinion could affect the safety of the subject, influence the findings of the trial, or impede the subject's ability to complete the trial.

Sponsors & Collaborators

• University of Rochester: lead
• Incyte Corporation: collaborator

Study Sites (1)

UR Medicine Dermatology College Town

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

ruxolitinib

Results Point of Contact

• Title: Anna De Benedetto, MD
• Organization: University of Rochester

anna_debenedetto@urmc.rochester.edu

(585) 275-7546

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 24, 2022
• Study Start: July 11, 2022
• Primary Completion: June 21, 2023
• Study Completion: December 31, 2024
• Last Updated: February 25, 2025
• Results First Posted: October 15, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)