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Janus Kinase (JAK) Inhibitor

Topical Ruxolitinib for Hand Eczema

Phase 1 & 2
Waitlist Available
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease severity graded as moderate to severe according to IGA (i.e., IGA ≥2).
Be older than 18 years old
Must not have
Females who are breastfeeding, pregnant, or anticipate becoming pregnant during the study time frame
Participants who have previously received JAK inhibitor therapy, systemic or topical.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Summary

This trial will test whether Ruxolitinib, a topical medication, is effective in treating Chronic Hand Dermatitis. The trial will be conducted at the University of Rochester Medical Center in Rochester, New York, and will require subjects to come to the URMC Dermatology Clinic for at least five visits.

Who is the study for?
This trial is for adults with Chronic Hand Dermatitis (CHD) who haven't responded well to standard creams or can't use them. They should have had CHD for more than 3 months or recurring episodes over the past year. People can't join if they've used certain skin treatments recently, are pregnant/breastfeeding, have unstable health conditions, a history of skin cancer on hands within 5 years, HIV, excessive hand washing, or known allergies to substances they can't avoid.
What is being tested?
The study tests Ruxolitinib cream's effectiveness in treating CHD at the University of Rochester Medical Center. Participants will visit the clinic five times and must meet specific criteria including having moderate to severe CHD despite previous treatments.
What are the potential side effects?
While not explicitly listed here, topical Ruxolitinib may cause side effects such as application site reactions (redness or irritation), headaches, and possibly increase infection risk due to its immune-modulating properties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is considered moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant, breastfeeding, or planning to become pregnant during the study.
Select...
I have previously received JAK inhibitor therapy.
Select...
I haven't taken any experimental or approved biologic drugs in the last 6 months.
Select...
My liver or kidney function is severely impaired and not stable.
Select...
I do not have HIV or any primary immunodeficiency disorder.
Select...
I have a serious infection on my hands.
Select...
I have skin inflammation needing treatment, not just on my hands.
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I have psoriasis needing treatment, not just on my hands.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent change in Hand Eczema Severity Index (HECSI)
Proportion of patients with chronic hand dermatitis improvement as assessed by Investigators Global Assessment

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036
33%
Anaemia
19%
Hypertension
17%
Nasopharyngitis
16%
Weight increased
14%
Herpes zoster
14%
Constipation
14%
Abdominal pain
14%
Headache
12%
Pruritus
12%
Back pain
12%
Epistaxis
12%
Pyrexia
12%
Dizziness
10%
Asthenia
10%
Fatigue
10%
Cough
10%
Oedema peripheral
10%
Arthralgia
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Haematoma
7%
Dyslipidaemia
7%
Pain in extremity
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Cystitis
3%
Blood creatine phosphokinase increased
3%
Bronchitis
3%
Paraesthesia
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Night sweats
2%
Peripheral artery thrombosis
2%
Vertigo
2%
Intervertebral disc protrusion
2%
Urethral stenosis
2%
Acute pulmonary oedema
2%
Ureterolithiasis
2%
Localised infection
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: All ParticipantsExperimental Treatment1 Intervention
You are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
859 Previous Clinical Trials
538,683 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
382 Previous Clinical Trials
57,032 Total Patients Enrolled
2 Trials studying Hand Eczema
186 Patients Enrolled for Hand Eczema

Media Library

Ruxolitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05293717 — Phase 1 & 2
Hand Eczema Research Study Groups: All Participants
Hand Eczema Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT05293717 — Phase 1 & 2
Ruxolitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05293717 — Phase 1 & 2
~6 spots leftby Sep 2025
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