Collecting samples from people with skin conditions and healthy volunteers

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

This study is collecting samples from people with different skin conditions and healthy volunteers to see how their biology differs and learn more about these conditions.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovaderm Research Inc. (other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT05994976 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect various biological samples from individuals with different inflammatory skin conditions, such as acne, atopic dermatitis, chronic hand eczema, hidradenitis suppurativa, and plaque psoriasis, as well as from healthy volunteers. The collected samples will be used for molecular characterization, including biomarker and gene expression analyses. Participants will undergo procedures to collect blood, oral, hair, skin samples, and skin surface materials to facilitate this research.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with specific inflammatory skin conditions or healthy individuals in good general health.

Not a fit: Patients with skin conditions not specified in the study or those under 18 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of inflammatory skin diseases and lead to improved diagnostic and therapeutic strategies.

How similar studies have performed: Other studies focusing on the molecular characterization of skin conditions have shown promise, indicating that this approach is supported by prior research.

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.

Where this trial is running

Montreal, Quebec

• Innovaderm Research Inc. — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Robert Bissonnette, MD — Innovaderm Research Inc.
• Study coordinator: Julie Bedoucha, MSc

Conditions: Acne, Atopic Dermatitis, Chronic Hand Eczema, Hidradenitis Suppurativa, Plaque Psoriasis, Palmoplantar Pustulosis