Chronic Hand EczemaNCT05026554
Characterization of Chronic Hand Eczema
An observational study of Chronic Hand Eczema and Atopic Dermatitis, run by Dr. Robert Bissonnette at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hand Eczema, Atopic Dermatitis
- What is being tested?
- Tape stripping
- How many people
- 270 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jun 2021to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Show all 22Show fewer
- 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.
- Subjects with only AD:
- Subject has clinically confirmed diagnosis of active atopic dermatitis, according to Hanifin and Rajka criteria.
- Subject has at least a 6-month history of AD and had no significant flares in AD for at least 4 weeks before Screening (information obtained from medical chart or subject's physician, or directly from the subject).
- Subject has moderate to severe AD as defined by a vIGA-AD score of ≥3 at Screening and Day 1.
- Subject has AD covering ≥0.5% of BSA at Screening and Day 1.
- Subject has an AD lesion covering ≥0.25% of BSA on the forearm at Screening and Day 1.Healthy Volunteers only:
- Subject is in good general health, according to the investigator's judgment based on medical history and physical examination.
Who cannot join
- 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.
Show all 35Show fewer
- 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.
- Subject has used alitretinoin, isotretinoin, acitretin or other systemic retinoids within 4 weeks before Day 1, or has not completely recovered from its side effects.
- Subject has used systemic treatments (other than biologics) that could have an impact on CHE less than 4 weeks prior to Day 1 (eg, calcineurin inhibitors, methotrexate, cyclosporin, hydroxycarbamide [hydroxyurea], azathioprine), or systemic steroids (including oral or injectable corticosteroids).
- Note: Intranasal corticosteroids, eye or ear drops containing corticosteroids, and inhaled corticosteroids for stable medical conditions are allowed.
- Subject has used dupilumab within 12 weeks prior to Day 1.
- Subject has received any UV-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day 1.
- Subject has had psoralen-UV-A (PUVA) treatment within 4 weeks prior to Day 1.
- Subjects with only AD:
- Subject has clinically infected AD.
- Subject has AD lesion on hand and/or feet at screening or Day 1.
- Subject has received an intravenous immunoglobulin (IVIg) therapy within 12 weeks prior to Day 1.
- 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 AD within 1 week prior to Day 1, including, but not limited to, topical corticosteroids, crisaborole, calcineurin inhibitors, ruxolitinib, tars, antimicrobials, medical devices, and bleach baths.
- Subject has used systemic treatments (other than biologics) that could affect AD less than 4 weeks prior to Day 1, including, but not limited to, retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids, baricitinib, upadacitinib, and abrocitinib.
- Subject has used dupilumab within 12 weeks prior to Day 1.
- Subject has received any UV-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day 1.
- Subject has had PUVA treatment within 4 weeks prior to Day 1. Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are allowed.
- Subject has used tralokinumab within 12 weeks prior to Day 1.
- Healthy Volunteers only:
- Subject has history of atopic dermatitis, allergic rhinitis, or asthma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Innovaderm Research
Montreal, Quebec, H2X 2V1
Robert Bissonnette, MD, MSc
About this study
Official title: Pathophysiological Characterization of Chronic Hand Eczema Subtypes and Atopic Dermatitis With Noninvasive Molecular and Imaging Techniques in Subjects With Moderate to Severe Chronic Hand Eczema, Subjects With Atopic Dermatitis, and Healthy Volunteers
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.
Read the detailed description
Prospective longitudinal study of adult patients with moderate to severe chronic hand eczema, subject with modreate to severe Atopic Dermatitis and healthy volenteers to assess changes in morphological parameters and molecular signatures with non-invasive techniques.In addition, disease severity and their association with occupation, smoking status, quality of life will be evaluated per CHE subtypes and compared to subjects with only AD. Samples and data collected from healthy volunteers will be used as controls in the analyses.
- Conditions
- Chronic Hand Eczema, Atopic Dermatitis
- Being tested
- Tape stripping
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tape strippingGenetic
Optional genetic analysis for chronic hand eczema
| Study group | Role | What they receive |
|---|---|---|
| CHE | Adults with moderate to severe chronic hand eczema Receives: Genetic: Tape stripping | |
| Healthy Volunteers | Healthy adults Receives: Genetic: Tape stripping | |
| Atopic Dermatitis | subjects with moderate to severe AD Receives: Genetic: Tape stripping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (3)
Determine disease severity impact on lifestyle
Evaluate correlation of lifestyle with disease severity. Lifestyle information will be captured with type of occupation performed daily by the subject. In addition, tobacco product usage will be collected with information on history (length of usage) and rate (the frequency of usage).
Measured: 12 months
Determine disease severity impact on quality of life
Evaluate correlation of quality of life with disease severity. Quality of life will be captured with Dermatology Life Quality Index Questionnaire (DLQI). DLQI is a 10-item questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each item is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Measured: 12 months
To biobank plasma, serum, whole blood, DNA (buffy coat), stool, skin surface material and skin tissue.
Blood and microbiome samples will be collected from all subjects. Blood samples will be collected for biomarker and gene expression analyses, and optional DNA analyses. Skin swab samples, and optional stool samples, will be collected for microbiome analyses, including bacterial load,diversity, and characterization. Collected samples not analyzed in them current study will be retained in a biobank for future research purposes.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start30 Jun 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hand EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Robert Bissonnette
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Robert Bissonnette, Innovaderm Research Inc.
- Investigators
- Robert Bissonnette, MD, MSc, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026554
- Sponsor's protocol ID
- INNO-5024
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2021
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Characterization of Chronic Hand Eczema Subtypes and Atopic Dermatitis With Noninvasive Molecular and Imaging Techniques in Subjects With Moderate to Severe Chronic Hand Eczema, Subjects With Atopic Dermatitis, and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05026554
- Acronym / sponsor ID
- INNO-5024
- Conditions
- Chronic Hand Eczema, Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Dr. Robert BissonnetteUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective longitudinal study of adult patients with moderate to severe chronic hand eczema, subject with modreate to severe Atopic Dermatitis and healthy volenteers to assess changes in morphological parameters and molecular signatures with non-invasive techniques.In addition, disease severity and their association with occupation, smoking status, quality of life will be evaluated per CHE subtypes and compared to subjects with only AD. Samples and data collected from healthy volunteers will be used as controls in the analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHE | – | Genetic: Tape strippingAdults with moderate to severe chronic hand eczema |
| Healthy Volunteers | – | Genetic: Tape strippingHealthy adults |
| Atopic Dermatitis | – | Genetic: Tape strippingsubjects with moderate to severe AD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (35 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tape strippingOptional genetic analysis for chronic hand eczema | Genetic | Atopic Dermatitis, CHE, Healthy Volunteers |
Primary outcome
Characterize differences in skin morphological parameters
Time frame: 12 months
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.
Characterize differences in skin molecular signature
Time frame: 12 months
Determine differences in skin molecular signatures between cohorts by comparing gene expression profiles from skin tissue collected with tape strips.
3 secondary outcomes
Determine disease severity impact on lifestyle
Time frame: 12 months
Determine disease severity impact on quality of life
Time frame: 12 months
To biobank plasma, serum, whole blood, DNA (buffy coat), stool, skin surface material and skin tissue.
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Hand Eczema
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingObservational study
PPDTM CorEvitasTM Chronic Hand Eczema (CHE) Drug Safety and Effectiveness Registry
Chronic Hand Eczema
Enrolling by invitationObservational study
Real-World Evidence: Effectiveness and Safety of Chronic Hand Eczema Treatment With Delgocitinib Cream
Chronic Hand Eczema (CHE)
Recruiting
Immune Signature of Chronic Hand Eczema Unveiled by Spatial Transcriptomics and Single-Cell Proteomics
Hand Eczema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Bissonnette, MD, MSc principal investigator
Innovaderm Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hand Eczema and Atopic Dermatitis, run by Dr. Robert Bissonnette at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Palijan, PhD (5145214285, apalijan@innovaderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize differences in skin morphological parameters (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.