Sebum Metabolomics and Lipidomics for Clinical Applications

Официальное название

Development of a Sample Collection Protocol and a Metabolomics/Lipidomics Analytical Strategy for Investigating Sebum and Its Clinical Applications

Обзор

This study aims to develop a standardized workflow for sebum sampling and metabolomics/lipidomics analysis using Sebutape. A total of 200 participants will be recruited, including healthy individuals, patients with skin diseases, individuals undergoing dermatological treatments or using skincare products, and a subset of healthy participants receiving short-term topical antibiotic intervention. The study will investigate sebum composition, skin microbiome profiles, and their interactions under different conditions to explore potential biomarkers and clinical applications.

Подробное описание

This study focuses on establishing a comprehensive Sebutape-based workflow for sebum metabolomics and lipidomics, including standardized sampling and extraction procedures and optimization of an LC-MS/MS pseudotargeted analytical platform. Sebutape samples will be collected from 200 participants across four groups: healthy individuals, patients with skin diseases or specific skin conditions, individuals undergoing dermatological treatments or using skincare products, and healthy participants receiving short-term topical antibiotic intervention. Each sample will be analyzed for lipidomic and metabolomic profiles, while parallel microbiome profiling will be performed using 16S rRNA sequencing. The study aims to evaluate reproducibility, analytical reliability, and lipid-microbe interactions, thereby identifying candidate biomarkers and elucidating pathogenic mechanisms in skin disorders.

Вмешательства

• Другое Sebutape sampling
  Non-invasive sebum sampling using Sebutape patches. Each participant will undergo standardized sampling procedures, with one patch used for metabolomics/lipidomics analysis and another for microbiome profiling. Samples will be stored at -80 °C for subsequent LC-MS/MS and 16S rRNA sequencing.
• Препарат Bacitracin/Polymyxin B/Neomycin ointment (Yentuogin ointment)
  Short-term topical antibiotic intervention using Yentuogin ointment containing Bacitracin, Polymyxin B, and Neomycin. Healthy participants will apply the ointment 1-2 times daily for up to 3 days. Sebutape samples will be collected before and after intervention to assess changes in sebum composition and skin microbiome.

Первичные конечные точки

• Concentration of Sebum Lipids Measured by LC-MS/MS [Срок оценки: From baseline (pre-intervention or pre-treatment) to post-intervention (approximately 1 day after completion of a 3-day intervention) or post-treatment (up to 3 months after treatment initiation, depending on treatment regimen)]
• Relative Abundance of Skin Microbiome Composition Assessed by Sequencing [Срок оценки: From baseline (pre-intervention or pre-treatment) to post-intervention (approximately 1 day after completion of a 3-day intervention) or post-treatment (up to 3 months after treatment initiation, depending on treatment regimen)]

Критерии участия

A. Healthy Participants

Критерии включения

• Individuals aged ≥20 years, regardless of sex or ethnicity, and assessed by the investigator to be in good health and suitable for participation.
• No diagnosed skin diseases or chronic systemic diseases.
• No use of medications or receipt of dermatological treatments that may affect sebum secretion or the skin microbiome within the past two weeks.

Критерии исключения

• Known allergy to Sebutape or similar adhesive tapes, or a history of related adverse reactions.
• Presence of acute or chronic skin diseases, or chronic systemic diseases.
• Use of medications or receipt of dermatological treatments that may affect sebum secretion or the skin microbiome within the past two weeks.
• Use of lotions, sunscreen, or other skincare products that may affect skin condition within 12 hours prior to sampling.
• Any other conditions deemed unsuitable for participation by the principal investigator.

B. Participants with Skin Diseases or Specific Skin Conditions

Критерии включения

• Individuals aged ≥20 years, regardless of sex or ethnicity, and assessed by the investigator to be suitable for participation.
• Diagnosed by a physician or clinically assessed as having one of the following:

• Acne
• Atopic dermatitis
• Seborrheic dermatitis
• Psoriasis
• Other common skin diseases
• Specific skin conditions (e.g., postmenopausal or aging-related skin changes)

Критерии исключения

• Known allergy to Sebutape or similar adhesive tapes, or a history of related adverse reactions.
• Severe disease that may compromise skin integrity or pose a risk to participant safety.
• Use of lotions, sunscreen, or other skincare products that may affect skin condition within 12 hours prior to sampling.
• Any other conditions deemed unsuitable for participation by the principal investigator.

C. Participants Receiving Dermatological Treatments or Using Skincare Products

Критерии включения

• Individuals aged ≥20 years, regardless of sex or ethnicity, and assessed by the investigator to be suitable for participation.
• Participants who, based on clinical needs or daily routines, are currently using or are expected to use or receive any of the following:

• Physician-prescribed topical dermatological medications
• Physician-prescribed systemic therapies (oral or injectable)
• Routine use of general skincare products
• Physician-directed non-invasive dermatological treatments

Критерии исключения

• Known allergy to Sebutape or similar adhesive tapes, or a history of related adverse reactions.
• Severe disease that may compromise skin integrity or pose a risk to participant safety.
• Use of lotions, sunscreen, or other skincare products that may affect skin condition within 12 hours prior to sampling.
• Any other conditions deemed unsuitable for participation by the principal investigator.

D. Healthy Participants Undergoing Short-term Antibiotic Intervention

Критерии включения

• Individuals aged ≥20 years, regardless of sex or ethnicity.
• Assessed by the investigator to be healthy, with skin condition suitable for the intervention used in this study.

Критерии исключения

• Known allergy to Sebutape or similar adhesive tapes, or a history of related adverse reactions.
• Known allergy or adverse reactions to the study intervention drug (topical antibiotic ointment containing bacitracin, polymyxin B, and neomycin).
• Presence of visible skin disease, wounds, infection, inflammation, or other abnormal skin conditions at the sampling site.
• Use of lotions, sunscreen, or other skincare products that may affect skin condition within 12 hours prior to sampling.
• Any other conditions deemed unsuitable for participation by the principal investigator.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07549828 · 202602076RINB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗