Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood samples collection, Oral samples collection, Hair samples collection, Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping).
- Who it may be relevant to
- Registry conditions: Acne, Atopic Dermatitis, Chronic Hand Eczema, Hidradenitis Suppurativa. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers for Molecular Characterization of Inflammatory Skin Diseases
Overview
The purpose of the study is to collect different samples for molecular characterization of inflammatory skin diseases.
Detailed description
This study is being conducted to collect samples from subjects with various skin conditions as well as healthy volunteers. Collected samples may be used for different analyses including, but not limited to, biomarker and gene expression analyses.
Interventions
- Procedure Blood samples collection
biomarkers and optional genetic analysis - Procedure Oral samples collection
biomarkers analysis - Procedure Hair samples collection
biomarkers analysis - Procedure Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)
biomarkers analysis - Procedure Skin surface material samples
biomarkers analysis - Procedure Drainage fluid samples collection
biomarkers analysis - Procedure Stool samples collection
biomarkers analysis
Primary outcome measures
- Untargeted biomarker approach with gene expression profile of skin samples [Time frame: Day 1]
- Exploratory biomarker and gene expression analyses. [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
All subjects:
- 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.
Healthy volunteers:
- Male or female subject aged 18 years or older, at the time of consent.
- Subject is in good general health, according to the investigator's judgment.
Subjects with Acne:
- Male or female subject aged 18 to 45 years old, inclusive, at the time of consent.
Subjects with AD:
- Male or female subject aged 18 years or older, at the time of consent.
- Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.
Subjects with CHE:
- Male or female subject aged 18 years or older, at the time of consent.
- 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).
Subjects with HS:
- Male or female subject aged 18 years or older, at the time of consent.
- Subject has a clinically confirmed diagnosis of active HS with a disease duration of ≥ 6 months before screening as determined by the investigator through subject interview and/or review of the medical history.
Subjects with PPP:
- Male or female subject aged 18 years or older at the time of consent.
- Subject has at least a 6-month history of PPP as defined by the presence of pustules on palms and/or soles, but without evidence of infection on palms and soles (information obtained from medical chart or subject's physician, or directly from the subject).
Subjects with psoriasis:
- Male or female subject aged 18 years or older, at the time of consent.
Exclusion criteria
All subjects:
- Subject is a female who is pregnant or who is planning to become pregnant during the study.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Innovaderm Research Inc. — Montreal
Identifiers
NCT: NCT05994976 · INNO-5034