Skin CancerDermaFlowNCT06989216
Multi-modal Quantitative Imaging of the Skin
An observational study of Skin Cancer and Skin Diseases, run by HJN Sverige AB/Neko Health at 3 sites in Sweden.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer, Skin Diseases, Atopic Dermatitis
- How many people
- 8,000 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Feb 2023to 1 Feb 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Atrium Health Care Centre
Stockholm
Andreea Valdman, MD, +46739392711, andreea@nekohealth.com
Andreea Valdman, MD
- Recruiting
Neko Health Centre Regeringsgatan
Stockholm
Andreea Valdman, +46739392711, andreea@nekohealth.com
Yuan Tan, yuan.tan@nekohealth.com
- Recruiting
Neko Health Centre Sibyllegatan
Stockholm
Andreea Valdman, MD, +46739392711, andreea@nekohealth.com
Andreea Valdman, MD
About this study
Official title: DermaFlow Alpha - Multi-modal Quantitative Imaging of the Skin
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.
- Conditions
- Skin Cancer, Skin Diseases, Atopic Dermatitis, Psoriasis, Raynaud Disease, Diabetic Foot
- Medical subject headings
- Skin Neoplasms, Skin Diseases, Dermatitis, Atopic, Psoriasis, Raynaud Disease, Diabetic Foot, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
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.
Measured: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
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.
Measured: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
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.
Measured: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
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.
Measured: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
Secondary outcomes (3)
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.
Measured: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
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.
Measured: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
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.
Measured: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Feb 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HJN Sverige AB/Neko Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreea Valdman, MD, Principal investigator, Neko Health AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989216
- Sponsor's protocol ID
- SKN-P2-CIP-220905
- Acronym
- DermaFlow
- Status last verified
- May 2025
- First submitted
- 1 Aug 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DermaFlow Alpha - Multi-modal Quantitative Imaging of the Skin
- ClinicalTrials.gov ID
- NCT06989216
- Acronym / sponsor ID
- DermaFlow / SKN-P2-CIP-220905
- Conditions
- Skin Cancer, Skin Diseases, Atopic Dermatitis, Psoriasis, Raynaud Disease, Diabetic Foot
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- HJN Sverige AB/Neko HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 25 May 2025 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity for detection of lesions requiring excision in comparison to visual inspection
Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
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.
Difference in body metrics between full-body 3D photography and traditional measurements
Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
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.
Sensitivity in detection of dermatological conditions with 2D images from full-body photography
Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
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.
Sensitivity in detection of new or significantly changed lesions, from macroscopic images using 2D and 3D full-body photography.
Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
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.
Correlation between thermal gradient in hands and/or feet with diagnosis of peripheral arterial disease or Raynaud's phenomenon
Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
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.
3 secondary outcomes
Thermal gradient of inflammatory area compared to surrounding skin to detect presence of psoriasis arthritis
Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
Association between thermal profile/local gradient and presence of inflammatory skin conditions.
Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
Identification of potential cancerous lesions by assessment of thermal profile of suspected lesions
Time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.
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 25 May 2025.
- Individual participant dataSharing planned: No
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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.
Andreea Valdman, MD principal investigator
Neko Health AB
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer and Skin Diseases, run by HJN Sverige AB/Neko Health at 3 sites in Sweden.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mattias Windå, MSc (0703169040, mattias@nekohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity for detection of lesions requiring excision in comparison to visual inspection (time frame: Typically same day as enrolment, or if follow-up then 1 year following enrolment.). The study lists 5 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 25 May 2025.