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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05994976
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Innovaderm Research Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Robert Bissonnette, MD
Principal Investigator Affiliation Innovaderm Research Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Arms & Interventions

Arms

: Healthy volunteers

Healthy adults

: Acne

Adult subjects aged 18 to 45 years old with acne

: AD

Adult subjects with Atopic Dermatitis (AD)

: CHE

Adult subjects with Chronic Hand Eczema (CHE)

: HS

Adult subjects with Hidradenitis suppurativa (HS)

: PPP

Adult subjects with Palmoplantar pustulosis (PPP)

: Psoriasis

Adult subjects with Psoriasis

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Innovaderm Research Inc., Montréal, Quebec, Canada

Status

Recruiting

Address

Innovaderm Research Inc.

Montréal, Quebec, H2X 2V1

Site Contact

Julie Bedoucha, MSc

jbedoucha@innovaderm.com

514-521-4285 #253

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