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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05994976
Other study ID # INNO-5034
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 17, 2023
Est. completion date August 2028

Study information

Verified date September 2023
Source Innovaderm Research Inc.
Contact Julie Bedoucha, MSc
Phone 514-521-4285
Email jbedoucha@innovaderm.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date August 2028
Est. primary completion date August 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Blood samples collection
biomarkers and optional genetic analysis
Oral samples collection
biomarkers analysis
Hair samples collection
biomarkers analysis
Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)
biomarkers analysis
Skin surface material samples
biomarkers analysis
Drainage fluid samples collection
biomarkers analysis
Stool samples collection
biomarkers analysis

Locations

Country Name City State
Canada Innovaderm Research Inc. Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Innovaderm Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exploratory biomarker and gene expression analyses. Day 1
Primary Untargeted biomarker approach with gene expression profile of skin samples Day 1
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