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.
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 Type
OBSERVATIONAL
Enrollment
270
Optional genetic analysis for chronic hand eczema
Innovaderm Research
Montreal, Quebec, Canada
RECRUITINGCharacterize 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.
Time frame: 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.
Time frame: 12 months
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).
Time frame: 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).
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Time frame: 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.
Time frame: 10 years