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NCT Number: NCT07549828

Sebum Metabolomics and Lipidomics for Clinical Applications

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • 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:
  • Acne
  • 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.

Treatment and study plan

Sebutape sampling

Other

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.

Bacitracin/Polymyxin B/Neomycin ointment (Yentuogin ointment)

Drug

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.

Primary outcomes

  1. Concentration of Sebum Lipids Measured by LC-MS/MS

    Time frame: 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.

  2. Relative Abundance of Skin Microbiome Composition Assessed by Sequencing

    Time frame: 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 (%).

Study contacts

Contact information is provided by the study sponsor or research team.

Ya-Chu Kuo, PhD

CONTACT

[email protected]

+886-2-3366-8766

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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