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

Recruiting

• Conditions: Chronic Hand Eczema; Plaque Psoriasis; Palmoplantar Pustulosis; Atopic Dermatitis; Acne; Hidradenitis Suppurativa
• Interventions: 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

• Registration Number: NCT05994976
• Lead Sponsor: Innovaderm Research Inc.

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-16
• Study Start: 2023-10-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2028-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHE	Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)	Adult subjects with Chronic Hand Eczema (CHE)
AD	Drainage fluid samples collection	Adult subjects with Atopic Dermatitis (AD)
CHE	Oral samples collection	Adult subjects with Chronic Hand Eczema (CHE)
Healthy volunteers	Blood samples collection	Healthy adults
Acne	Oral samples collection	Adult subjects aged 18 to 45 years old with acne
HS	Hair samples collection	Adult subjects with Hidradenitis suppurativa (HS)
HS	Drainage fluid samples collection	Adult subjects with Hidradenitis suppurativa (HS)
HS	Stool samples collection	Adult subjects with Hidradenitis suppurativa (HS)
PPP	Drainage fluid samples collection	Adult subjects with Palmoplantar pustulosis (PPP)
Psoriasis	Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)	Adult subjects with Psoriasis
Psoriasis	Stool samples collection	Adult subjects with Psoriasis
AD	Blood samples collection	Adult subjects with Atopic Dermatitis (AD)
Healthy volunteers	Hair samples collection	Healthy adults
Healthy volunteers	Skin surface material samples	Healthy adults
Healthy volunteers	Stool samples collection	Healthy adults
Acne	Hair samples collection	Adult subjects aged 18 to 45 years old with acne
AD	Skin surface material samples	Adult subjects with Atopic Dermatitis (AD)
CHE	Skin surface material samples	Adult subjects with Chronic Hand Eczema (CHE)
CHE	Drainage fluid samples collection	Adult subjects with Chronic Hand Eczema (CHE)
HS	Skin surface material samples	Adult subjects with Hidradenitis suppurativa (HS)
Acne	Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)	Adult subjects aged 18 to 45 years old with acne
CHE	Blood samples collection	Adult subjects with Chronic Hand Eczema (CHE)
Healthy volunteers	Drainage fluid samples collection	Healthy adults
Acne	Drainage fluid samples collection	Adult subjects aged 18 to 45 years old with acne
Acne	Stool samples collection	Adult subjects aged 18 to 45 years old with acne
AD	Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)	Adult subjects with Atopic Dermatitis (AD)
Healthy volunteers	Oral samples collection	Healthy adults
Healthy volunteers	Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)	Healthy adults
Acne	Blood samples collection	Adult subjects aged 18 to 45 years old with acne
AD	Oral samples collection	Adult subjects with Atopic Dermatitis (AD)
CHE	Stool samples collection	Adult subjects with Chronic Hand Eczema (CHE)
Psoriasis	Drainage fluid samples collection	Adult subjects with Psoriasis
Acne	Skin surface material samples	Adult subjects aged 18 to 45 years old with acne
AD	Hair samples collection	Adult subjects with Atopic Dermatitis (AD)
AD	Stool samples collection	Adult subjects with Atopic Dermatitis (AD)
CHE	Hair samples collection	Adult subjects with Chronic Hand Eczema (CHE)
PPP	Oral samples collection	Adult subjects with Palmoplantar pustulosis (PPP)
PPP	Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)	Adult subjects with Palmoplantar pustulosis (PPP)
Psoriasis	Hair samples collection	Adult subjects with Psoriasis
HS	Blood samples collection	Adult subjects with Hidradenitis suppurativa (HS)
HS	Oral samples collection	Adult subjects with Hidradenitis suppurativa (HS)
HS	Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)	Adult subjects with Hidradenitis suppurativa (HS)
PPP	Blood samples collection	Adult subjects with Palmoplantar pustulosis (PPP)
PPP	Hair samples collection	Adult subjects with Palmoplantar pustulosis (PPP)
PPP	Skin surface material samples	Adult subjects with Palmoplantar pustulosis (PPP)
PPP	Stool samples collection	Adult subjects with Palmoplantar pustulosis (PPP)
Psoriasis	Blood samples collection	Adult subjects with Psoriasis
Psoriasis	Oral samples collection	Adult subjects with Psoriasis
Psoriasis	Skin surface material samples	Adult subjects with Psoriasis

Primary Outcome Measures

Name	Time	Method
Untargeted biomarker approach with gene expression profile of skin samples	Day 1
Exploratory biomarker and gene expression analyses.	Day 1

Trial Locations

Locations (1)

Innovaderm Research Inc.; 🇨🇦 Montréal, Quebec, Canada