Multi-modal Quantitative Imaging of the Skin

NCT06989216 | Recruiting

• 1 other identifier: SKN-P2-CIP-220905
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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

  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.

  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

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HJN Sverige AB/Neko Health: lead

Study Sites (3)

Atrium Health Care Centre

Stockholm, Sweden

RECRUITING

Neko Health Centre Regeringsgatan

Stockholm, Sweden

RECRUITING

Neko Health Centre Sibyllegatan

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms; Skin Diseases; Dermatitis, Atopic; Psoriasis; Raynaud Disease; Diabetic Foot; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin and Connective Tissue Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Diabetic Angiopathies; Foot Ulcer; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Andreea Valdman, MD

  Neko Health AB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattias Windå, MSc

CONTACT

0703169040; mattias@nekohealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: May 25, 2025
• Study Start: February 1, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)