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

NCT ID: NCT05994976

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-17

Study Completion Date

2028-08-31

Brief Summary

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The purpose of the study is to collect different samples for molecular characterization of inflammatory skin diseases.

Detailed Description

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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.

Conditions

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Acne Atopic Dermatitis Chronic Hand Eczema Hidradenitis Suppurativa Plaque Psoriasis Palmoplantar Pustulosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy volunteers

Healthy adults

Blood samples collection

Intervention Type PROCEDURE

biomarkers and optional genetic analysis

Oral samples collection

Intervention Type PROCEDURE

biomarkers analysis

Hair samples collection

Intervention Type PROCEDURE

biomarkers analysis

Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)

Intervention Type PROCEDURE

biomarkers analysis

Skin surface material samples

Intervention Type PROCEDURE

biomarkers analysis

Drainage fluid samples collection

Intervention Type PROCEDURE

biomarkers analysis

Stool samples collection

Intervention Type PROCEDURE

biomarkers analysis

Acne

Adult subjects aged 18 to 45 years old with acne

Blood samples collection

Intervention Type PROCEDURE

biomarkers and optional genetic analysis

Oral samples collection

Intervention Type PROCEDURE

biomarkers analysis

Hair samples collection

Intervention Type PROCEDURE

biomarkers analysis

Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)

Intervention Type PROCEDURE

biomarkers analysis

Skin surface material samples

Intervention Type PROCEDURE

biomarkers analysis

Drainage fluid samples collection

Intervention Type PROCEDURE

biomarkers analysis

Stool samples collection

Intervention Type PROCEDURE

biomarkers analysis

AD

Adult subjects with Atopic Dermatitis (AD)

Blood samples collection

Intervention Type PROCEDURE

biomarkers and optional genetic analysis

Oral samples collection

Intervention Type PROCEDURE

biomarkers analysis

Hair samples collection

Intervention Type PROCEDURE

biomarkers analysis

Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)

Intervention Type PROCEDURE

biomarkers analysis

Skin surface material samples

Intervention Type PROCEDURE

biomarkers analysis

Drainage fluid samples collection

Intervention Type PROCEDURE

biomarkers analysis

Stool samples collection

Intervention Type PROCEDURE

biomarkers analysis

CHE

Adult subjects with Chronic Hand Eczema (CHE)

Blood samples collection

Intervention Type PROCEDURE

biomarkers and optional genetic analysis

Oral samples collection

Intervention Type PROCEDURE

biomarkers analysis

Hair samples collection

Intervention Type PROCEDURE

biomarkers analysis

Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)

Intervention Type PROCEDURE

biomarkers analysis

Skin surface material samples

Intervention Type PROCEDURE

biomarkers analysis

Drainage fluid samples collection

Intervention Type PROCEDURE

biomarkers analysis

Stool samples collection

Intervention Type PROCEDURE

biomarkers analysis

HS

Adult subjects with Hidradenitis suppurativa (HS)

Blood samples collection

Intervention Type PROCEDURE

biomarkers and optional genetic analysis

Oral samples collection

Intervention Type PROCEDURE

biomarkers analysis

Hair samples collection

Intervention Type PROCEDURE

biomarkers analysis

Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)

Intervention Type PROCEDURE

biomarkers analysis

Skin surface material samples

Intervention Type PROCEDURE

biomarkers analysis

Drainage fluid samples collection

Intervention Type PROCEDURE

biomarkers analysis

Stool samples collection

Intervention Type PROCEDURE

biomarkers analysis

PPP

Adult subjects with Palmoplantar pustulosis (PPP)

Blood samples collection

Intervention Type PROCEDURE

biomarkers and optional genetic analysis

Oral samples collection

Intervention Type PROCEDURE

biomarkers analysis

Hair samples collection

Intervention Type PROCEDURE

biomarkers analysis

Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)

Intervention Type PROCEDURE

biomarkers analysis

Skin surface material samples

Intervention Type PROCEDURE

biomarkers analysis

Drainage fluid samples collection

Intervention Type PROCEDURE

biomarkers analysis

Stool samples collection

Intervention Type PROCEDURE

biomarkers analysis

Psoriasis

Adult subjects with Psoriasis

Blood samples collection

Intervention Type PROCEDURE

biomarkers and optional genetic analysis

Oral samples collection

Intervention Type PROCEDURE

biomarkers analysis

Hair samples collection

Intervention Type PROCEDURE

biomarkers analysis

Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)

Intervention Type PROCEDURE

biomarkers analysis

Skin surface material samples

Intervention Type PROCEDURE

biomarkers analysis

Drainage fluid samples collection

Intervention Type PROCEDURE

biomarkers analysis

Stool samples collection

Intervention Type PROCEDURE

biomarkers analysis

Interventions

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Blood samples collection

biomarkers and optional genetic analysis

Intervention Type PROCEDURE

Oral samples collection

biomarkers analysis

Intervention Type PROCEDURE

Hair samples collection

biomarkers analysis

Intervention Type PROCEDURE

Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)

biomarkers analysis

Intervention Type PROCEDURE

Skin surface material samples

biomarkers analysis

Intervention Type PROCEDURE

Drainage fluid samples collection

biomarkers analysis

Intervention Type PROCEDURE

Stool samples collection

biomarkers analysis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

All subjects:

1. Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
2. Subject must be willing to comply with all study procedures and must be available for the duration of the study.

Healthy volunteers:
3. Male or female subject aged 18 years or older, at the time of consent.
4. Subject is in good general health, according to the investigator's judgment.

Subjects with Acne:
5. Male or female subject aged 18 to 45 years old, inclusive, at the time of consent.

Subjects with AD:
6. Male or female subject aged 18 years or older, at the time of consent.
7. Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.

Subjects with CHE:
8. Male or female subject aged 18 years or older, at the time of consent.
9. 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:
10. Male or female subject aged 18 years or older, at the time of consent.
11. 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:
12. Male or female subject aged 18 years or older at the time of consent.
13. 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:
14. Male or female subject aged 18 years or older, at the time of consent.

Exclusion Criteria

All subjects:

1. Subject is a female who is pregnant or who is planning to become pregnant during the study.
2. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Innovaderm Research Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Bissonnette, MD

Role: PRINCIPAL_INVESTIGATOR

Innovaderm Research Inc.

Locations

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Innovaderm Research Inc.

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Julie Bedoucha, MSc

Role: CONTACT

514-521-4285 ext. 253

Facility Contacts

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Julie Bedoucha, MSc

Role: primary

514-521-4285 ext. 253

Other Identifiers

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INNO-5034

Identifier Type: -

Identifier Source: org_study_id

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