Non-invasive imaging to measure skin composition and structure
Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure
This study is testing a new non-invasive imaging technology to see if it can accurately measure different components and structures of skin in people visiting their primary care doctor, especially those at higher risk for heart issues or diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HJN Sverige AB/Neko Health Industry-sponsored |
| Locations | 3 sites (Stockholm and 2 other locations) |
| Trial ID | NCT06976073 on ClinicalTrials.gov |
What this trial studies
This clinical investigation explores a non-invasive technology called Spatial Frequency Domain Imaging (SFDI) to assess the microcirculatory structure and function of skin tissue in a primary care population. The study aims to evaluate the technology's ability to measure molecular composition, including levels of deoxy- and oxyhemoglobin, melanin, and water, as well as structural properties at different depths. Participants will undergo SFDI assessments during routine primary care visits, with additional evaluations for those at increased cardiovascular risk or with diabetes. The study also compares SFDI results with existing reference systems to validate its effectiveness.
Who should consider this trial
Good fit: Ideal candidates include adult patients from primary care settings, particularly those with known cardiovascular disease risk or diabetes.
Not a fit: Patients with cognitive impairments, severe disorders, or damaged skin in the area of interest may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could provide a non-invasive method for early detection of circulatory deficiencies and skin-related conditions in patients at risk for cardiovascular disease and diabetes.
How similar studies have performed: While this approach is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients part of the regular healthcare patient flow at the investigational sites, or as separately invited to participate in this investigation. * Patients with signed informed consent Exclusion Criteria: * Cognitive impairment * Patients unable to understand the oral and written study information in Swedish or English * Other severe disorder or terminal disease * Patients unable to provide an informed consent * Patient´s with damaged, scarred or non-intact skin within the skin area of interest.
Where this trial is running
Stockholm and 2 other locations
- Atrium Health Care Centre — Stockholm, Sweden (Recruiting)
- Neko Health Centre, Regeringsgatan — Stockholm, Sweden (Recruiting)
- Neko Health Centre, Sibyllegatan — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Samuel Rodgers, MD — HJN Sverige AB/Neko Health AB
- Study coordinator: Mattias Windå, MSc
- Email: mattias@nekohealth.com
- Phone: +46703169040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.