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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 • 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%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
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%
Blood creatine phosphokinase increased
3%
Cystitis
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%
Localised infection
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
2%
Vertigo
2%
Peripheral artery thrombosis
2%
Ureterolithiasis
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
836 Previous Clinical Trials
518,148 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,145 Total Patients Enrolled
2 Trials studying Hand Eczema
186 Patients Enrolled for Hand 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being included in this experiment?
"Affirmative. Records on clinicaltrials.gov verify that this research trial, which was initially uploaded to the website on July 11th 2022, is actively recruiting individuals for participation. Only 15 volunteers need to be sourced from a single medical centre."
Answered by AI
Is enrollment still an option for this research endeavor?
"Affirmative. According to information hosted on clinicaltrials.gov, this research is currently enrolling individuals; the initial posting was published on July 11th 2022 and most recently updated August 9th 2022. The trial seeks 15 participants from one medical centre."
Answered by AI
Is there any way I can participate in this research?
"This clinical trial is recruiting 15 volunteers, aged 18-75 years old that are suffering from chronic dermatitis. Specifically, the disease severity must have been graded as moderate to severe via IGA and participants must also have unsuccessfully attempted treatment with corticosteroids or calcineurin inhibitors in the past year prior to screening for this study."
Answered by AI
Is the minimum age requirement for this trial less than 80 years old?
"To be considered for this trial, potential participants must fall between the age range of 18 and 75. For those younger than 18 years old or over 65, there are 96 clinical trials to explore and 153 studies respectively."
Answered by AI
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