Development of a Sample Collection Protocol and a Metabolomics/Lipidomics Analytical Strategy for Investigating Sebum and Its Clinical Applications
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Concentration of Sebum Lipids Measured by LC-MS/MS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A. Healthy Participants
- •Inclusion Criteria:
- •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.
排除标准
- •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
- •Inclusion Criteria:
- •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:
- •Atopic dermatitis
- •Seborrheic dermatitis
- •Psoriasis
- •Other common skin diseases
- •Specific skin conditions (e.g., postmenopausal or aging-related skin changes)
- •Exclusion Criteria:
- •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
- •Inclusion Criteria:
- •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
- •Exclusion Criteria:
- •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
- •Inclusion Criteria:
- •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.
- •Exclusion Criteria:
- •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.
研究组 & 干预措施
Sebutape sampling and analysis
All participants will undergo non-invasive sebum sampling using Sebutape. Samples will be analyzed for metabolomic and lipidomic profiles using LC-MS/MS, and microbiome profiling will be performed using 16S rRNA sequencing. Subgroups include 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.
干预措施: Sebutape sampling (Other)
Sebutape sampling and analysis
All participants will undergo non-invasive sebum sampling using Sebutape. Samples will be analyzed for metabolomic and lipidomic profiles using LC-MS/MS, and microbiome profiling will be performed using 16S rRNA sequencing. Subgroups include 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.
干预措施: Bacitracin/Polymyxin B/Neomycin ointment (Yentuogin ointment) (Drug)
结局指标
主要结局
Concentration of Sebum Lipids Measured by LC-MS/MS
时间窗: 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)
Sebum lipid levels will be measured using Sebutape sampling followed by LC-MS/MS analysis. Results will be reported as normalized intensity.
Relative Abundance of Skin Microbiome Composition Assessed by Sequencing
时间窗: 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)
Skin microbiome profiles will be assessed using sequencing-based analysis and reported as relative abundance (%).
次要结局
未报告次要终点