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Not yet recruitingNCT07549828Updated Apr 24, 2026

Sebum Metabolomics and Lipidomics for Clinical Applications

An interventional study of Sebutape sampling and Bacitracin/Polymyxin B/Neomycin ointment (Yentuogin ointment) in Acne, Atopic Dermatitis and Seborrheic Dermatitis, sponsored by National Taiwan University Hospital. Not yet recruiting. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Acne
  • Atopic Dermatitis
  • Seborrheic Dermatitis
  • Psoriasis
  • Healthy Subjects (HS)

Keywords

  • Sebum
  • Lipidomics
  • Metabolomics
  • Skin microbiome
  • Sebutape
  • LC-MS/MS
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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 · Drug: Bacitracin/Polymyxin B/Neomycin ointment (Yentuogin ointment)

Interventions

  • OtherSebutape 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.

  • DrugBacitracin/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.

05

What researchers measure

Primary outcomes

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

    Sebum lipid levels will be measured using Sebutape sampling followed by LC-MS/MS analysis. Results will be reported as normalized intensity.

    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)

  2. Relative Abundance of Skin Microbiome Composition Assessed by Sequencing

    Skin microbiome profiles will be assessed using sequencing-based analysis and reported as relative abundance (%).

    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)

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

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

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07549828
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Apr 24, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Mar 31, 2029 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Apr 24, 2026

Study contacts

Ya-Chu Kuo, PhD
Contact
iris890402@gmail.com
+886-2-3366-8766
Ching_Hua Kuo
principal investigator · National Taiwan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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