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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
No Placebo-Only Group
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 belowSelect...
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.
Select...
I have psoriasis needing treatment, not just on my hands.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
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 Mean 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 • NCT0203803633%
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%
Paraesthesia
3%
Bronchitis
3%
Cystitis
3%
Blood creatine phosphokinase increased
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Peripheral artery thrombosis
2%
Vertigo
2%
Acute pulmonary oedema
2%
Night sweats
2%
Intervertebral disc protrusion
2%
Urethral stenosis
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1170
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
872 Previous Clinical Trials
550,075 Total Patients Enrolled
5 Trials studying Eczema
435 Patients Enrolled for Eczema
Incyte CorporationIndustry Sponsor
393 Previous Clinical Trials
63,950 Total Patients Enrolled
25 Trials studying Eczema
14,387 Patients Enrolled for Eczema
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had skin cancer on my hands in the last 5 years.I haven't used any antibiotic creams on my hands in the last 2 weeks.I am not pregnant, breastfeeding, or planning to become pregnant during the study.I have previously received JAK inhibitor therapy.I haven't taken any immune-suppressing drugs or steroids in the last 4 weeks.You have a low blood cell count that is concerning to the doctors.I haven't used any skin treatments on my hands, except my own moisturizers, in the last week.I haven't taken any experimental or approved biologic drugs in the last 6 months.You have a known allergy to a specific substance and cannot avoid contact with it.My liver or kidney function is severely impaired and not stable.My condition is considered moderate to severe.I have had hand eczema for over 3 months or it has come back twice in the last year.I haven't started or changed my antihistamine dose in the last 2 weeks.I do not have HIV or any primary immunodeficiency disorder.I have not taken antibiotics in the last 4 weeks.I have not had light therapy on my hands in the last 4 weeks.I haven't used any skin immune creams or steroids on my hands in the last 2 weeks.I have a serious infection on my hands.Topical treatments haven't worked for me in the past year, or I can't use them for health reasons.I have skin inflammation needing treatment, not just on my hands.I have psoriasis needing treatment, not just on my hands.My hand dermatitis is mainly due to my hands being in water for over 2 hours a day or washing them more than 20 times a day.I have had stubborn warts on my hands in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: All Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.