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 range18 Years – 65 Years
SexALL
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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.
✕. Subject has used systemic antibiotics within 2 weeks prior to Day 1.
✕. Subject has used topical antibiotics within 1 week prior to Day 1.
What they're measuring
1
Characterize differences in skin morphological parameters
Timeframe: 12 months
2
Characterize differences in skin molecular signature
. 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.