Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Study Details
Study Description
Brief Summary
The purpose of the study is to collect different samples for molecular characterization of inflammatory skin diseases.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthy volunteers Healthy adults |
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
|
| Acne Adult subjects aged 18 to 45 years old with acne |
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
|
| AD Adult subjects with Atopic Dermatitis (AD) |
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
|
| CHE Adult subjects with Chronic Hand Eczema (CHE) |
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
|
| HS Adult subjects with Hidradenitis suppurativa (HS) |
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
|
| PPP Adult subjects with Palmoplantar pustulosis (PPP) |
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
|
| Psoriasis Adult subjects with Psoriasis |
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
|
Outcome Measures
Primary Outcome Measures
- Exploratory biomarker and gene expression analyses. [Day 1]
- Untargeted biomarker approach with gene expression profile of skin samples [Day 1]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Innovaderm Research Inc. | Montréal | Quebec | Canada | H2X 2V1 |
Sponsors and Collaborators
- Innovaderm Research Inc.
Investigators
- Principal Investigator: Robert Bissonnette, MD, Innovaderm Research Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INNO-5034