AcneNCT07549828
Sebum Metabolomics and Lipidomics for Clinical Applications
A study testing Sebutape sampling and Bacitracin/Polymyxin B/Neomycin ointment (Yentuogin ointment) in people with Acne and Atopic Dermatitis, run by National Taiwan University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne, Atopic Dermatitis, Seborrheic Dermatitis
- What is being tested?
- Sebutape sampling and Bacitracin/Polymyxin B/Neomycin ointment (Yentuogin ointment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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
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- Atopic dermatitis
- Seborrheic dermatitis
- Psoriasis
- Other common skin diseases
- Specific skin conditions (e.g., postmenopausal or aging-related skin changes)
- 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
- 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.
Who cannot join
- 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.
- Participants with Skin Diseases or Specific Skin Conditions
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- 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.
- Participants Receiving Dermatological Treatments or Using Skincare Products
- 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.
- Healthy Participants Undergoing Short-term Antibiotic Intervention
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Acne, Atopic Dermatitis, Seborrheic Dermatitis, Psoriasis, Healthy Subjects (HS)
- Being tested
- Sebutape sampling, Bacitracin/Polymyxin B/Neomycin ointment (Yentuogin ointment)
- Keywords
- Sebum, Lipidomics, Metabolomics, Skin microbiome, Sebutape, LC-MS/MS
- Medical subject headings
- Acne Vulgaris, Dermatitis, Atopic, Dermatitis, Seborrheic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sebutape samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sebutape sampling; Drug: Bacitracin/Polymyxin B/Neomycin ointment (Yentuogin ointment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (%).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching_Hua Kuo, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549828
- Sponsor's protocol ID
- 202602076RINB
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data due to ethical considerations and privacy concerns. Only aggregated results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Sample Collection Protocol and a Metabolomics/Lipidomics Analytical Strategy for Investigating Sebum and Its Clinical Applications
- ClinicalTrials.gov ID
- NCT07549828
- Acronym / sponsor ID
- 202602076RINB
- Conditions
- Acne, Atopic Dermatitis, Seborrheic Dermatitis, Psoriasis, Healthy Subjects (HS)
- Keywords
- Sebum, Lipidomics, Metabolomics, Skin microbiome, Sebutape, LC-MS/MS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sebutape sampling and analysis | Experimental | Other: Sebutape sampling, Drug: Bacitracin/Polymyxin B/Neomycin ointment (Yentuogin ointment)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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
- 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:
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sebutape samplingNon-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. | Other | Sebutape sampling and analysis |
| 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. | Drug | Sebutape sampling and analysis |
Primary outcome
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.
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 (%).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data due to ethical considerations and privacy concerns. Only aggregated results will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ching_Hua Kuo principal investigator
National Taiwan University
Questions about this trial
What is this clinical trial studying?
A study testing Sebutape sampling and Bacitracin/Polymyxin B/Neomycin ointment (Yentuogin ointment) in people with Acne and Atopic Dermatitis, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ya-Chu Kuo, PhD (+886-2-3366-8766, iris890402@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.