Characterization of Chronic Hand Eczema

NCT05026554 | Recruiting DMC

• 1 other identifier: INNO-5024
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hand Eczema; Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Characterize differences in skin morphological parameters

  Determine differences in skin morphological parameters between cohorts assessed with Hand Eczema Severity Index (HECSI). The HECSI scoring system incorporates both the extent and the intensity of the disease. Each hand will be divided into five areas (fingertips, fingers \[except the tips\], palms, back of hands and wrists). For each of these areas the intensity of the six following clinical signs: erythema, induration ⁄ papulation, vesicles, fissuring, scaling and oedema will be graded on the following scale: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe. For each location (total of both hands) the affected area will be given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms.

  12 months

• Characterize differences in skin molecular signature

  Determine differences in skin molecular signatures between cohorts by comparing gene expression profiles from skin tissue collected with tape strips.

  12 months

Secondary Outcomes (3)

• Determine disease severity impact on lifestyle

  12 months

• Determine disease severity impact on quality of life

  12 months

• To biobank plasma, serum, whole blood, DNA (buffy coat), stool, skin surface material and skin tissue.

  10 years

Study Arms (3)

CHE

Adults with moderate to severe chronic hand eczema

Genetic: Tape stripping

Healthy Volunteers

Healthy adults

Genetic: Tape stripping

Atopic Dermatitis

subjects with moderate to severe AD

Genetic: Tape stripping

Interventions

Tape stripping GENETIC

Optional genetic analysis for chronic hand eczema

Atopic Dermatitis; CHE; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 140 adult subjects will be enrolled in the study: 120 subjects with moderate to severe chronic hand eczema, and 20 healthy volunteers.

You may qualify if:

• All subjects:
• 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.
• CHE subjects only:
• 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:
• Atopic hand eczema (without wet-work or excessive contact with irritants)
• Irritant contact hand eczema without atopic disease
• Hyperkeratotic hand eczema without atopic disease
• Vesicular hand dermatitis without atopic disease
• Allergic contact hand eczema without atopic disease
• Idiopathic hand eczema without wet-work, excessive contact with irritants, atopic disease, hyperkeratotic morphology, allergic contact hand eczema and vesicular hand eczema.

You may not qualify if:

• All subjects:
• 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.
• 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.
• CHE subjects only:
• Subject has clinically infected chronic hand eczema on hands and/or wrists.
• Subject with suspected or proven hand eczema protein contact dermatitis.
• Subject has used doxepin within 1 week prior to Day 1.
• Subject has used hydroxyzine or diphenhydramine within 1 week prior to Day 1.
• Subject has used any topical medicated treatment that could affect CHE within 1 week prior to Day 1, including, but not limited to, topical corticosteroids, topical retinoids, crisaborole, calcineurin inhibitors, tars, antimicrobials, medical devices, and bleach baths.

Sponsors & Collaborators

• Dr. Robert Bissonnette: lead

Study Sites (1)

Innovaderm Research

Montreal, Quebec, H2X 2V1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, skin tissue

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Robert Bissonnette, MD, MSc

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Palijan, PhD

CONTACT

5145214285; apalijan@innovaderm.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 30, 2021
• Study Start: June 30, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)