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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05994976
• Other study ID #: INNO-5034
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Acne
• Atopic Dermatitis
• Chronic Hand Eczema
• Dermatitis
• Hidradenitis
• Hidradenitis Suppurativa
• Palmoplantar Pustulosis
• Plaque Psoriasis
• Psoriasis
• Skin Diseases

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