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HepatoSkin pilot study for non invasive fatty liver disease screening

HepatoSkin : Pilot Study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260118004
Enrollment
20
Registered
2026-01-18
Start date
2026-02-09
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

The primary health condition studied in this research is fatty liver disease, with emphasis on early-stage fatty liver disease. Fatty liver disease is a metabolic condition characterized by excessive fat accumulation in liver cells and is commonly associated with obesity, insulin resistance, and abnormal lipid metabolism. The condition often develops without obvious clinical symptoms, especially in the early stages, making early detection and screening challenging. This study focuses on indivi

Interventions

The intervention consists of a non invasive skin fluorescence related imaging procedure using the HepatoSkin prototype device. The device uses controlled low intensity 405 nm light to illuminate the f
Experimental Device
HepatoSkin skin fluorescence imaging

Sponsors

Student initiated research project. The study is initiated and managed by the student research team without institutional or commercial sponsorship.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adults who are legally able to provide informed consent and agree to participate voluntarily in the study. 2. Individuals diagnosed with fatty liver disease by a physician based on standard clinical assessment, including blood tests and abdominal ultrasound, or healthy adults without a history or current diagnosis of fatty liver disease who represent the target population for screening. 3. Participants who are able to understand the study procedures and comply with all study requirements, including skin imaging and clinical data collection. 4. Individuals with intact skin on the forearm suitable for skin imaging, without wounds, infections, or conditions that may interfere with optical measurements. 5. Participants who are willing to undergo non invasive skin imaging using low intensity light and standard clinical liver assessments as part of the study protocol. 6. Individuals who are able to attend the study visit and complete all required procedures on the same day. 7. Participants who do not have physical limitations that prevent proper positioning of the forearm during the imaging procedure. 8. Individuals who agree to the use of their anonymized data for research analysis related to fatty liver disease screening.

Exclusion criteria

Exclusion criteria: 1. Individuals with a current or past diagnosis of chronic liver diseases other than fatty liver disease, including viral hepatitis or liver cirrhosis. 2. Participants with a history of liver cancer or other malignancies affecting liver function. 3. Individuals with excessive alcohol consumption that is considered a primary cause of fatty liver disease according to clinical guidelines. 4. Participants with metabolic or systemic diseases that may strongly affect skin metabolism or fluorescence signals, such as uncontrolled diabetes mellitus or severe endocrine disorders. 5. Individuals with skin conditions on the forearm that may interfere with optical imaging, including active dermatitis, infection, scarring, or significant pigmentation abnormalities. 6. Participants who have used topical medications, cosmetic products, or skin treatments on the forearm that could affect skin fluorescence within a short period before imaging. 7. Individuals with medical conditions that limit safe participation in blood sampling or abdominal ultrasound procedures. 8. Participants with physical disabilities or musculoskeletal conditions that prevent proper positioning of the forearm during the imaging procedure. 9. Individuals who are unable to comply with study procedures or follow study instructions as judged by the investigators.

Design outcomes

Primary

MeasureTime frame
HepatoSkin skin autofluorescence imaging for fatty liver disease screening Single time point during the study visit Skin autofluorescence intensity measured from forearm images captured under controlled blue light using an optical imaging device.

Secondary

MeasureTime frame
Difference in skin autofluorescence intensity between participants with fatty liver disease and healthy participants Single time point during the study visit Skin autofluorescence intensity measured from forearm images captured under controlled blue light using an optical imaging device.

Countries

Thailand

Contacts

Public ContactPijitwan Nuntaphap

Montfort College Chiang Mai

info_mcs@montfort.ac.th053 245572

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026