Characterization of Chronic Hand Eczema (NCT05026554) | Clinical Trial Compass
RecruitingNot Applicable
Characterization of Chronic Hand Eczema
Canada270 participantsStarted 2021-06-30
Plain-language summary
Prospective longitudinal study to characterize Choronic Hand Eczema (CHE) subtypes and Atopic Dermatitis (AD) with noninvasive molecular and imaging techniques, and assess changes through time and its association with quality of life.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects aged 18 to 65 years, inclusive, at the time of consent.
. Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
. Subject must be willing to comply with all study procedures and must be available for the duration of the study.
. Subject has at least a 6-month history of CHE before Screening (information obtained from medical chart or subject's physician, or directly from the subject).
. Subject has moderate to severe CHE as defined by an IGA score of ≥3 at Screening and Day 1.
. Subject has CHE covering ≥0.25% of BSA on palmar surface of hands at Screening and Day 1.
. Subjects has CHE that can be categorized in one of the following CHE subtypes at Day 1:
. Subject has clinically confirmed diagnosis of active atopic dermatitis, according to Hanifin and Rajka criteria.
Exclusion criteria
. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterize differences in skin morphological parameters
Timeframe: 12 months
2
Characterize differences in skin molecular signature
. Subject has used systemic antibiotics within 2 weeks prior to Day 1.
. Subject has used topical antibiotics within 1 week prior to Day 1.
. Subject has used topical products containing urea or salicylic acid within 1 week prior to Day 1.
. Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
. Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
. Subject has had excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to Day 1. Use of sunscreen products are recommended when exposure cannot be avoided.
. Subject is a female who is pregnant or who is planning to become pregnant during the study.