Chronic Hand DermatitisPhase 1/2NCT05293717
Topical Ruxolitinib in Chronic Hand Dermatitis
A Phase 1/2 study testing Ruxolitinib in people with Chronic Hand Dermatitis, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hand Dermatitis
- What is being tested?
- Ruxolitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 31 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UR Medicine Dermatology College Town
Rochester, New York, 14642
About this study
Official title: Topical Ruxolitinib (Jak1/Jak2 Inhibitor) in Chronic Hand Dermatitis Attenuates Inflammation and Enhances Skin Barrier Repair
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.
Read the 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.
- Conditions
- Chronic Hand Dermatitis
- Being tested
- Ruxolitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
1.5% Ruxolitinib cream
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | You are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily. Receives: Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start11 Jul 2022
- Primary completion21 Jun 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Hand DermatitisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Principal investigator, Anna De Benedetto, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293717
- Sponsor's protocol ID
- STUDY00006638
- Status last verified
- Feb 2025
- First submitted
- 7 Mar 2022
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Ruxolitinib (Jak1/Jak2 Inhibitor) in Chronic Hand Dermatitis Attenuates Inflammation and Enhances Skin Barrier Repair
- ClinicalTrials.gov ID
- NCT05293717
- Acronym / sponsor ID
- STUDY00006638
- Conditions
- Chronic Hand Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Drug: RuxolitinibYou are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib1.5% Ruxolitinib cream | Drug | All Participants |
Primary outcome
Proportion of Patients With Chronic Hand Dermatitis Improvement as Assessed by Investigators Global Assessment
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ruxolitinib in people with Chronic Hand Dermatitis, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Chronic Hand Dermatitis Improvement as Assessed by Investigators Global Assessment (time frame: week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.