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

Study Overview
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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.

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

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

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers<br>Healthy adults | Procedure: Blood samples collection<br>* biomarkers and optional genetic analysis<br>Procedure: Oral samples collection<br>* biomarkers analysis<br>Procedure: Hair samples collection<br>* biomarkers analysis<br>Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)<br>* biomarkers analysis<br>Procedure: Skin surface material samples<br>* biomarkers analysis<br>Procedure: Drainage fluid samples collection<br>* biomarkers analysis<br>Procedure: Stool samples collection<br>* biomarkers analysis<br>|
| Acne<br>Adult subjects aged 18 to 45 years old with acne | Procedure: Blood samples collection<br>* biomarkers and optional genetic analysis<br>Procedure: Oral samples collection<br>* biomarkers analysis<br>Procedure: Hair samples collection<br>* biomarkers analysis<br>Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)<br>* biomarkers analysis<br>Procedure: Skin surface material samples<br>* biomarkers analysis<br>Procedure: Drainage fluid samples collection<br>* biomarkers analysis<br>Procedure: Stool samples collection<br>* biomarkers analysis<br>|
| AD<br>Adult subjects with Atopic Dermatitis (AD) | Procedure: Blood samples collection<br>* biomarkers and optional genetic analysis<br>Procedure: Oral samples collection<br>* biomarkers analysis<br>Procedure: Hair samples collection<br>* biomarkers analysis<br>Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)<br>* biomarkers analysis<br>Procedure: Skin surface material samples<br>* biomarkers analysis<br>Procedure: Drainage fluid samples collection<br>* biomarkers analysis<br>Procedure: Stool samples collection<br>* biomarkers analysis<br>|
| CHE<br>Adult subjects with Chronic Hand Eczema (CHE) | Procedure: Blood samples collection<br>* biomarkers and optional genetic analysis<br>Procedure: Oral samples collection<br>* biomarkers analysis<br>Procedure: Hair samples collection<br>* biomarkers analysis<br>Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)<br>* biomarkers analysis<br>Procedure: Skin surface material samples<br>* biomarkers analysis<br>Procedure: Drainage fluid samples collection<br>* biomarkers analysis<br>Procedure: Stool samples collection<br>* biomarkers analysis<br>|
| HS<br>Adult subjects with Hidradenitis suppurativa (HS) | Procedure: Blood samples collection<br>* biomarkers and optional genetic analysis<br>Procedure: Oral samples collection<br>* biomarkers analysis<br>Procedure: Hair samples collection<br>* biomarkers analysis<br>Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)<br>* biomarkers analysis<br>Procedure: Skin surface material samples<br>* biomarkers analysis<br>Procedure: Drainage fluid samples collection<br>* biomarkers analysis<br>Procedure: Stool samples collection<br>* biomarkers analysis<br>|
| PPP<br>Adult subjects with Palmoplantar pustulosis (PPP) | Procedure: Blood samples collection<br>* biomarkers and optional genetic analysis<br>Procedure: Oral samples collection<br>* biomarkers analysis<br>Procedure: Hair samples collection<br>* biomarkers analysis<br>Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)<br>* biomarkers analysis<br>Procedure: Skin surface material samples<br>* biomarkers analysis<br>Procedure: Drainage fluid samples collection<br>* biomarkers analysis<br>Procedure: Stool samples collection<br>* biomarkers analysis<br>|
| Psoriasis<br>Adult subjects with Psoriasis | Procedure: Blood samples collection<br>* biomarkers and optional genetic analysis<br>Procedure: Oral samples collection<br>* biomarkers analysis<br>Procedure: Hair samples collection<br>* biomarkers analysis<br>Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)<br>* biomarkers analysis<br>Procedure: Skin surface material samples<br>* biomarkers analysis<br>Procedure: Drainage fluid samples collection<br>* biomarkers analysis<br>Procedure: Stool samples collection<br>* biomarkers analysis<br>|

What is the study measuring?
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Primary Outcome Measures

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