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

Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers for Molecular Characterization of Inflammatory Skin Diseases

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

Study Overview

• Status: Recruiting
• Conditions: Plaque Psoriasis; Atopic Dermatitis; Hidradenitis Suppurativa; Palmoplantar Pustulosis; Acne; Chronic Hand Eczema
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Julie Bedoucha, MSc; Phone Number: 253 514-521-4285; Email: jbedoucha@innovaderm.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Recruiting
      • Innovaderm Research Inc.
      • Contact: Julie Bedoucha, MSc; Phone Number: 253 514-521-4285; Email: jbedoucha@innovaderm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Exploratory biomarker and gene expression analyses.	Day 1
Untargeted biomarker approach with gene expression profile of skin samples	Day 1

Collaborators and Investigators

• Sponsor: Innovaderm Research Inc.
• Investigators: Principal Investigator: Robert Bissonnette, MD, Innovaderm Research Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Infections; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Papulosquamous; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Skin Diseases, Genetic; Skin Diseases, Eczematous; Acneiform Eruptions; Sebaceous Gland Diseases; Dermatitis; Hidradenitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; Psoriasis; Dermatitis, Atopic; Acne Vulgaris
• Other Study ID Numbers: INNO-5034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No