Sebum Metabolomics and Lipidomics for Clinical Applications

April 17, 2026 updated by: National Taiwan University Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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 (%).
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Ching_Hua Kuo, National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202602076RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share individual participant data due to ethical considerations and privacy concerns. Only aggregated results will be published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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