NCT07549828

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Apr 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Mar 2029

Study Start

First participant enrolled

April 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 6, 2026

Last Update Submit

April 17, 2026

Conditions

Keywords

SebumLipidomicsMetabolomicsSkin microbiomeSebutapeLC-MS/MS

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    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)

Study Arms (1)

Sebutape sampling and analysis

EXPERIMENTAL

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 samplingDrug: Bacitracin/Polymyxin B/Neomycin ointment (Yentuogin ointment)

Interventions

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.

Sebutape sampling and analysis

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.

Sebutape sampling and analysis

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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)
  • Known allergy to Sebutape or similar adhesive tapes, or a history of related adverse reactions.
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acne VulgarisDermatitis, AtopicDermatitis, SeborrheicPsoriasis

Interventions

Bacitracin

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Ching_Hua Kuo

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 24, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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