Clinical trial NCT05994976: Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Official title: Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers for Molecular Characterization of Inflammatory Skin Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acne
Atopic Dermatitis
Chronic Hand Eczema
Hidradenitis Suppurativa
Plaque Psoriasis
Palmoplantar Pustulosis
Lead sponsor: Innovaderm Research Inc.
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Untargeted biomarker approach with gene expression profile of skin samples
timeFrame: Day 1
measure: Exploratory biomarker and gene expression analyses.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
Study officials:
affiliation: Innovaderm Research Inc.
name: Robert Bissonnette, MD
role: PRINCIPAL_INVESTIGATOR
References: