Characterization of Chronic Hand Eczema
Study Details
Study Description
Brief Summary
Prospective longitudinal study of adult patients with moderate to severe chronic hand eczema to characterize the disease and evaluate its association with quality of life.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Prospective longitudinal study of adult patients with moderate to severe chronic hand eczema to characterize the pathophysiology of chronic hand eczema and assess changes in morphological parameters and molecular signatures with non-invasive techniques.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CHE Adults with moderate to severe chronic hand eczema |
Genetic: Tape stripping
Optional genetic analysis for chronic hand eczema
|
| Healthy Volunteers Healthy adults |
Genetic: Tape stripping
Optional genetic analysis for chronic hand eczema
|
Outcome Measures
Primary Outcome Measures
- Characterize differences in skin morphological parameters [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 [12 months]
Determine differences in skin molecular signatures between cohorts by comparing gene expression profiles from skin tissue collected with tape strips.
Secondary Outcome Measures
- Determine disease severity impact on lifestyle [12 months]
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).
- Determine disease severity impact on quality of life [12 months]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female subjects aged 18 to 65 years, inclusive, at the time of consent.
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Subject is willing to participate and is capable of giving informed consent.
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Subject must be willing to comply with all study procedures and must be available for the duration of the study.
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CHE subjects: has moderate to severe chronic hand eczema described as IGA score of 3 or greater.
Healthy volunteers: in good general health.
Exclusion Criteria:
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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.
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Subject has used topical antibiotics within 1 week prior to Day 1.
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Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1.
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Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Innovaderm Research | Montreal | Quebec | Canada | H2X 2V1 |
Sponsors and Collaborators
- Dr. Robert Bissonnette
Investigators
- Principal Investigator: Robert Bissonnette, MD, MSc, Innovaderm Research Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INNO-5024