Characterization of Chronic Hand Eczema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorDr. Robert Bissonnette
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tape stripping
GeneticOptional genetic analysis for chronic hand eczema
Treatment groups
270 Participants
are divided into 3 treatment groupsGroup A: CHE1 intervention
Group B: Healthy Volunteers1 intervention
Group C: Atopic Dermatitis1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months2
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 monthsSecondary outcomes
1
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 months2
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).
Time frame
12 months3
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Robert Bissonnette
Lead sponsor
Innovaderm Research Inc.
Sponsor institution
Source ClinicalTrials.gov