Chronic Hand Dermatitis
Conditions
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.
Detailed description
This is a single-center study anticipating to enroll 15 participants with chronic hand dermatitis. Eligible participants will receive Ruxolitinib to apply twice daily for 12 weeks. Participants will be required to be seen every 4 weeks until week 16.
Interventions
DRUGRuxolitinib
1.5% Ruxolitinib cream
Sponsors
Incyte Corporation
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 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. * Participants with clinically significant cytopenia at screening * Participants with severely impaired liver or kidney function and unstable. * Participants who have previously received JAK inhibitor therapy, systemic or topical. * History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV), or the subject taking antiretroviral medications. * Females who are breastfeeding, pregnant, or anticipate becoming pregnant during the study time frame * History of skin cancer on hands within 5 years. * History of recalcitrant warts on hands within 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Chronic Hand Dermatitis Improvement as Assessed by Investigators Global Assessment | 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. |
| Percent Change in Mean Hand Eczema Severity Index (HECSI) | 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. |
Countries
United States
Participant flow
Pre-assignment details
20 subjects were consented but 4 failed screening leaving 16 participants who started the intervention
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 51.0 years STANDARD_DEVIATION 15.7 |
| Duration of chronic hand dermatitis (CHD) | 7.5 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| mean Hand Eczema Severity Index | 56.2 units on a scale STANDARD_DEVIATION 24.2 |
| number of participants who previously attempted taking CHD therapy acitretin | 3 Participants |
| number of participants who previously attempted taking CHD therapy calcipotriene | 1 Participants |
| number of participants who previously attempted taking CHD therapy high-potency topical steroids | 16 Participants |
| number of participants who previously attempted taking CHD therapy methotrexate | 3 Participants |
| number of participants who previously attempted taking CHD therapy mycophenolate | 1 Participants |
| number of participants who previously attempted taking CHD therapy oral steroids | 3 Participants |
| number of participants who previously attempted taking CHD therapy phototherapy | 3 Participants |
| number of participants who previously attempted taking CHD therapy tacrolimus | 4 Participants |
| number of participants with an Investigators Global Assessment (IGA) score of 3 or more IGA-3 | 8 Participants |
| number of participants with an Investigators Global Assessment (IGA) score of 3 or more IGA-4 | 8 Participants |
| Number of participants with atopic CHD subtype | 7 participants |
| number of participants with hyperkeratotic morphology | 7 participants |
| number of participants with mixed morphology | 1 Participants |
| number of participants with recurrent vesicular morphology | 1 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 2 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
Primary
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.
Time frame: baseline to week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Percent Change in Mean Hand Eczema Severity Index (HECSI) | -86.2 percent change of HECSI index | Standard Error 3.72 |
p-value: <0.001ANOVA
Primary
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.
Time frame: week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Proportion of Patients With Chronic Hand Dermatitis Improvement as Assessed by Investigators Global Assessment | 0.53 proportion of participants |