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Sebum Metabolomics and Lipidomics for Clinical Applications

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07549828
Enrollment
200
Registered
2026-04-24
Start date
2026-04-01
Completion date
2029-03-31
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Sebum, Lipidomics, Metabolomics, Skin microbiome, Sebutape, LC-MS/MS

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.

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.

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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
Concentration of Sebum Lipids Measured by LC-MS/MSFrom 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 SequencingFrom 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 (%).

Contacts

CONTACTYa-Chu Kuo, PhD
iris890402@gmail.com+886-2-3366-8766
PRINCIPAL_INVESTIGATORChing_Hua Kuo

National Taiwan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026