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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Untargeted biomarker approach with gene expression profile of skin samples [Срок оценки: Day 1]
• Exploratory biomarker and gene expression analyses. [Срок оценки: Day 1]

Критерии участия

Критерии включения

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.
• 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.
• Subject is in good general health, according to the investigator's judgment.

Subjects with Acne:

• 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.
• 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.
• 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.
• 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.
• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• Innovaderm Research Inc. — Montreal

Идентификаторы

NCT: NCT05994976 · INNO-5034

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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