Clinical trial NCT06989216: Multi-modal Quantitative Imaging of the Skin
Official title: DermaFlow Alpha - Multi-modal Quantitative Imaging of the Skin
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skin Cancer
Skin Diseases
Atopic Dermatitis
Psoriasis
Raynaud Disease
Diabetic Foot
Peripheral Arterial Disease
Lead sponsor: HJN Sverige AB/Neko Health
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients visiting the clinical sites, seeking care, or as separately invited, are offered to participate in this investigation. This includes sub-groups of patients with suspected skin cancer, acne, rosacea, psoriasis, eczema, PAD and Raynaud's.

Brief summary: This clinical trial is about evaluating the suitability of multi-modal imaging technology, which covers virtually the entire body, to evaluate the possibility of screening and early detection of disease.

Detailed description: This clinical investigation aims to evaluate the feasibility of full-body multi-modal imaging for screening, monitoring and diagnostic support purposes in primary care, by assessing accuracy of body measurements and sensitivity and correlation to disease. The performance in detection of skin cancer, peripheral arterial disease, Raynaud's phenomenon and dermatological conditions are within the scope of this investigation.

The multi-modal technology is based on camera systems, which can capture high-resolution 2D and 3D color images (visible spectrum) and thermal images (infrared spectrum). The appearance, shape, color, etc. and topography of lesions is captured by the color 2D camera of the system and can thus be inspected / quantified. Thermal images are used to capture thermal gradients which may be indicative of microcirculatory changes. The 3D camera is used to ensure that 2D color data and thermal data can be geometrically aligned, thus being able to compare characteristics of the two data types from the very same skin segment / lesion. Furthermore, it enables geometrical measurements of the lesions.

The participants mainly consist of a prospective primary care population, that undergo an investigation at a primary care visit. Full-body images (front and back) of all participants are captured during the visit. Participants receive a questionnaire to fill in on-site, where they state whether they have/have had any of the diseases and conditions part of the investigation. In some subjects, body measurements (circumference and distance) will be acquired manually as part of the primary care flow. Repeated yearly measurements may be performed in subjects who are interested.

Eligibility criteria: Inclusion criteria:

* Adult patients that are 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
* Patients not able to keep balance, while standing up with closed eyes, without any aid
* Claustrophobic patients

Primary outcomes:
measure: Sensitivity for detection of lesions requiring excision in comparison to visual inspection
timeFrame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
measure: Difference in body metrics between full-body 3D photography and traditional measurements
timeFrame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
measure: Sensitivity in detection of dermatological conditions with 2D images from full-body photography
timeFrame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
measure: Sensitivity in detection of new or significantly changed lesions, from macroscopic images using 2D and 3D full-body photography.
timeFrame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
measure: Correlation between thermal gradient in hands and/or feet with diagnosis of peripheral arterial disease or Raynaud's phenomenon
timeFrame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
Secondary outcomes:
measure: Thermal gradient of inflammatory area compared to surrounding skin to detect presence of psoriasis arthritis
timeFrame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
measure: Association between thermal profile/local gradient and presence of inflammatory skin conditions.
timeFrame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
measure: Identification of potential cancerous lesions by assessment of thermal profile of suspected lesions
timeFrame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Atrium Health Care Centre
city: Stockholm
country: Sweden
facility: Neko Health Centre Regeringsgatan
city: Stockholm
country: Sweden
facility: Neko Health Centre Sibyllegatan
Study officials:
affiliation: Neko Health AB
name: Andreea Valdman, MD
role: PRINCIPAL_INVESTIGATOR
References: