Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT05994976 |
Recruitment Status :
Recruiting
First Posted : August 16, 2023
Last Update Posted : November 18, 2023
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Condition or disease | Intervention/treatment |
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Acne Atopic Dermatitis Chronic Hand Eczema Hidradenitis Suppurativa Plaque Psoriasis Palmoplantar Pustulosis | 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 |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers for Molecular Characterization of Inflammatory Skin Diseases |
Actual Study Start Date : | October 17, 2023 |
Estimated Primary Completion Date : | August 2028 |
Estimated Study Completion Date : | August 2028 |
Group/Cohort | Intervention/treatment |
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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 |
- Exploratory biomarker and gene expression analyses. [ Time Frame: Day 1 ]
- Untargeted biomarker approach with gene expression profile of skin samples [ Time Frame: Day 1 ]
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
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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.
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Subject is in good general health, according to the investigator's judgment.
Subjects with Acne:
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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.
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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.
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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.
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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.
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05994976
Contact: Julie Bedoucha, MSc | 514-521-4285 ext 253 | jbedoucha@innovaderm.com |
Canada, Quebec | |
Innovaderm Research Inc. | Recruiting |
Montréal, Quebec, Canada, H2X 2V1 | |
Contact: Julie Bedoucha, MSc 514-521-4285 ext 253 jbedoucha@innovaderm.com | |
Principal Investigator: Robert Bissonnette, MD |
Principal Investigator: | Robert Bissonnette, MD | Innovaderm Research Inc. |
Responsible Party: | Innovaderm Research Inc. |
ClinicalTrials.gov Identifier: | NCT05994976 |
Other Study ID Numbers: |
INNO-5034 |
First Posted: | August 16, 2023 Key Record Dates |
Last Update Posted: | November 18, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hidradenitis Suppurativa Psoriasis Dermatitis Hidradenitis Skin Diseases Skin Diseases, Papulosquamous Sweat Gland Diseases |
Skin Diseases, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Suppuration |