Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT05994976

Recruitment Status : Recruiting

First Posted : August 16, 2023

Last Update Posted : November 18, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Innovaderm Research Inc.

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
Acne Atopic Dermatitis Chronic Hand Eczema Hidradenitis Suppurativa Plaque Psoriasis Palmoplantar Pustulosis	Procedure: Blood samples collection Procedure: Oral samples collection Procedure: Hair samples collection Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping) Procedure: Skin surface material samples Procedure: Drainage fluid samples collection Procedure: Stool samples collection

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

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Study Type :	Observational
Estimated Enrollment :	500 participants
Observational Model:	Cohort
Time Perspective:	Cross-Sectional
Official Title:	Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers for Molecular Characterization of Inflammatory Skin Diseases
Actual Study Start Date :	October 17, 2023
Estimated Primary Completion Date :	August 2028
Estimated Study Completion Date :	August 2028

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hidradenitis suppurativa

MedlinePlus related topics: Skin Conditions

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease Generalized Pustular Psoriasis Pustulosis Palmaris Et Plantaris

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	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. [ Time Frame: Day 1 ]
Untargeted biomarker approach with gene expression profile of skin samples [ Time Frame: Day 1 ]

Biospecimen Retention: Samples With DNA

Blood, stool, saliva, skin sample, lipid, sebum, microbiome, microorganism, hair, draining fluid

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Approximately 200 healthy volunteers and approximately 300 subjects with acne, atopic dermatitis (AD), chronic hand eczema (CHE), hidradenitis suppurativa (HS), palmoplantar pustulosis (PPP), and/or psoriasis will be included in this study.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05994976

Contacts

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Contact: Julie Bedoucha, MSc	514-521-4285 ext 253	jbedoucha@innovaderm.com

Locations

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Canada, Quebec
Innovaderm Research Inc.	Recruiting
Montréal, Quebec, Canada, H2X 2V1
Contact: Julie Bedoucha, MSc 514-521-4285 ext 253 jbedoucha@innovaderm.com
Principal Investigator: Robert Bissonnette, MD

Sponsors and Collaborators

Innovaderm Research Inc.

Investigators

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Principal Investigator:	Robert Bissonnette, MD	Innovaderm Research Inc.

More Information

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Responsible Party:	Innovaderm Research Inc.
ClinicalTrials.gov Identifier:	NCT05994976
Other Study ID Numbers:	INNO-5034
First Posted:	August 16, 2023 Key Record Dates
Last Update Posted:	November 18, 2023
Last Verified:	September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Hidradenitis Suppurativa Psoriasis Dermatitis Hidradenitis Skin Diseases Skin Diseases, Papulosquamous Sweat Gland Diseases	Skin Diseases, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Suppuration

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