ClinicalTrials.gg
RecruitingNCT06989216DermaFlowUpdated May 25, 2025

Multi-modal Quantitative Imaging of the Skin

An observational study in Skin Cancer, Skin Diseases and Atopic Dermatitis, sponsored by HJN Sverige AB/Neko Health. Recruiting at 3 sites in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by HJN Sverige AB/Neko Health · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies in Skin Neoplasms with a site in Sweden — 10 open to participants now, 10 under way, 1 of them phase 3. Skin Neoplasms · Sweden.

Started
2023
with 4 others
Observational
8 of 19
6 open now
Registered
14th of 19
by date
Lead sponsor
2 of 19
HJN Sverige AB/Neko Health

Among the 19 studies in Skin Neoplasms with a site in Sweden, this one is one of 5 that started in 2023, is one of 8 observational ones, and was the 14th registered.

Skin Neoplasms

604 studies on the registry are indexed under Skin Neoplasms; 126 are open to participants now.

Browse Skin Neoplasms studies →

Open to participants now

10 of the 19 studies in Skin Neoplasms with a site in Sweden are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 104 Skin Neoplasms studies recruiting now, 84 (81%) set no upper age limit and 9 (9%) stop at 75 or younger; 15 take children under 18; 25 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies in Skin Neoplasms with a site in Sweden, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Skin Cancer
  • Skin Diseases
  • Atopic Dermatitis
  • Psoriasis
  • Raynaud Disease
  • Diabetic Foot
  • Peripheral Arterial Disease
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients that are part of the regular healthcare patient flow at the sites, or as separately invited to participate in this investigation.
  • Patients with signed

Exclusion criteria

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
  • Patients not able to keep balance, while standing up with closed eyes, without any aid
  • Claustrophobic patients
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • patient_cohort

    The study participants mainly consist of a prospective primary care 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 skin cancer and dermatological conditions.

06

What researchers measure

Primary outcomes

  1. Sensitivity for detection of lesions requiring excision in comparison to visual inspection

    Evaluate the sensitivity of detecting lesions that required excision by inspection and labelling of full-body color images acquired by full-body photography. Manual labelling of images acquired by full-body photography will be compared to ocular inspection by doctor on-site, performed as part of a standard primary care flow. An expert reviewer blinded to outcome from ocular inspection will perform the manual labelling of images.

    Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.

  2. Difference in body metrics between full-body 3D photography and traditional measurements

    Evaluation of the mean difference in estimated body height, body circumference measurements and distance measurements (carotid centre - suprasternal notch, carotid centre - femoral centre and suprasternal notch - symphysis) using 3D images acquired by full-body photography compared to manual measurement using standard tape measures or height measurement tools. Difference is reported in metric units.

    Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.

  3. Sensitivity in detection of dermatological conditions with 2D images from full-body photography

    Percentage of all dermatological (eczema, psoriasis, rosacea), identified by self-reported diagnosis or by ocular inspection by a healthcare professional, which can be identified by 2D images from full-body photography (remote assessment by a trained healthcare professional, blinded to the outcome). The categories of assessment conclusion may include: 1. Cleared, no presence of specified condition 2. Diagnosed with condition 3. Further diagnostic steps are needed.

    Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.

  4. Sensitivity in detection of new or significantly changed lesions, from macroscopic images using 2D and 3D full-body photography.

    Sensitivity in detection of whether there are new or changed lesions on the visible parts of the body, based on a set of 2D and 3D images acquired using full-body photography. Expert reviewers with competence in lesion assessment will review images from subjects who have had no changed lesions and those who have had an excised lesion at second visit. . Images from initial and follow-up visit will be compared side-to-side. The expert reviewer will then classify, based on a collation of 2D and 3D images, into categories: 1. Significantly changed lesion 2. New lesion 3. No changed lesion.

    Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.

  5. Correlation between thermal gradient in hands and/or feet with diagnosis of peripheral arterial disease or Raynaud's phenomenon

    Evaluate correlation between thermal temperature gradient in thermal images acquired using full-body photography and diagnosis of peripheral arterial disease (PAD) and Raynaud's phenomenon. Confirmation of pathology presence is based on self-reported diagnosis from an on-site questionnaire. Alternatively, diagnosis is based on information from the participant's electronic health record if they are seeking care for a condition following their study visit.

    Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.

Secondary outcomes

  1. Thermal gradient of inflammatory area compared to surrounding skin to detect presence of psoriasis arthritis

    Thermal profile (local gradient / relative temperature difference) related to presence of psoriasis arthritis, determined by self-reported diagnosis and/or diagnosis extracted from electronic health record.

    Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.

  2. Association between thermal profile/local gradient and presence of inflammatory skin conditions.

    Thermal profile (absolute temperature)/local gradient (relative temperature difference) in relation to presence of inflammatory skin condition determined by self-reported diagnosis, and/or diagnosis extracted from electronic health record.

    Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.

  3. Identification of potential cancerous lesions by assessment of thermal profile of suspected lesions

    Thermal gradient (relative temperature difference from thermal images between lesion and surrounding tissue) of suspected lesions that have been cleared to lesions determined to be cancerous. Lesions are pre-labelled by expert reviewer with relevant experience.

    Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2023 (actual). Primary completion is estimated for Feb 2026, 36 months after the start.

Of 78 observational studies under Skin Neoplasms, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 248. This study's planned 36 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2023
First posted
May 25, 2025
StartActual
Feb 1, 2023
Primary completionEst.
Feb 1, 2026
CompletionEst.
Feb 1, 2026
Last update
May 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06989216
Lead sponsor
HJN Sverige AB/Neko Health
Responsible party
Sponsor
First posted
May 25, 2025
Start date
Feb 1, 2023
Primary completion
Feb 1, 2026 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
May 25, 2025

Study contacts

Mattias Windå, MSc
Contact
mattias@nekohealth.com
0703169040
Andreea Valdman, MD
principal investigator · Neko Health AB

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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