Trial Outcomes & Findings for Topical Ruxolitinib in Chronic Hand Dermatitis (NCT NCT05293717)

Last Updated: 2025-02-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

week 12

Results posted on

2025-02-25

Participant Flow

20 subjects were consented but 4 failed screening leaving 16 participants who started the intervention

Participant milestones

Participant milestones
Measure	All Participants You are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily. Ruxolitinib: 1.5% Ruxolitinib cream
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants You are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily. Ruxolitinib: 1.5% Ruxolitinib cream
Overall Study Physician Decision	1

Baseline Characteristics

Topical Ruxolitinib in Chronic Hand Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=16 Participants You are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily. Ruxolitinib: 1.5% Ruxolitinib cream
Age, Continuous	51.0 years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants
Duration of chronic hand dermatitis (CHD)	7.5 years STANDARD_DEVIATION 8.8 • n=5 Participants
mean Hand Eczema Severity Index	56.2 units on a scale STANDARD_DEVIATION 24.2 • n=5 Participants
Number of participants with atopic CHD subtype	7 participants n=5 Participants
number of participants with hyperkeratotic morphology	7 participants n=5 Participants
number of participants with recurrent vesicular morphology	1 participants n=5 Participants
number of participants with mixed morphology	1 Participants n=5 Participants
number of participants who previously attempted taking CHD therapy high-potency topical steroids	16 Participants n=5 Participants
number of participants who previously attempted taking CHD therapy tacrolimus	4 Participants n=5 Participants
number of participants who previously attempted taking CHD therapy methotrexate	3 Participants n=5 Participants
number of participants who previously attempted taking CHD therapy oral steroids	3 Participants n=5 Participants
number of participants who previously attempted taking CHD therapy mycophenolate	1 Participants n=5 Participants
number of participants who previously attempted taking CHD therapy phototherapy	3 Participants n=5 Participants
number of participants who previously attempted taking CHD therapy calcipotriene	1 Participants n=5 Participants
number of participants who previously attempted taking CHD therapy acitretin	3 Participants n=5 Participants
number of participants with an Investigators Global Assessment (IGA) score of 3 or more IGA-3	8 Participants n=5 Participants
number of participants with an Investigators Global Assessment (IGA) score of 3 or more IGA-4	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: week 12

Outcome measures

Outcome measures
Measure	All Participants n=15 Participants You are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily. Ruxolitinib: 1.5% Ruxolitinib cream
Proportion of Patients With Chronic Hand Dermatitis Improvement as Assessed by Investigators Global Assessment	0.53 proportion of participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	All Participants n=15 Participants You are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily. Ruxolitinib: 1.5% Ruxolitinib cream
Percent Change in Mean Hand Eczema Severity Index (HECSI)	-86.2 percent change of HECSI index Standard Error 3.72

Adverse Events

All Participants

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=16 participants at risk You are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily. Ruxolitinib: 1.5% Ruxolitinib cream
Renal and urinary disorders kidney stone	6.2% 1/16 • 12 weeks

Other adverse events

Other adverse events
Measure	All Participants n=16 participants at risk You are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily. Ruxolitinib: 1.5% Ruxolitinib cream
Infections and infestations Upper Respiratory Infection	6.2% 1/16 • 12 weeks
Infections and infestations scalp abscess	6.2% 1/16 • 12 weeks

Additional Information

Anna De Benedetto, MD

University of Rochester

Phone: (585) 275-7546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place