An observational study in Skin Condition, Skin Abnormalities and Malignancy, sponsored by AI Labs Group S.L. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by AI Labs Group S.L · Observational
The goal of this observational study is to learn if an artificial intelligence (AI) tool helps primary care practitioners better identify skin conditions. The study focuses on adults with suspected skin pathologies, including tumor, inflammatory, and infectious diseases.
The main questions it aims to answer are:
Participants will:
This prospective, observational study evaluates the clinical utility of an artificial intelligence (AI)-based computational software device designed to support primary care practitioners (PCPs) and dermatologists in managing skin pathologies. The research explores whether the device can enhance diagnostic accuracy and optimize the referral process from primary care to specialized dermatology services.
Study Methodology and Design
The investigation is designed as an analytical study of a clinical case series. Key technical aspects include:
Quality Assurance and Registry Procedures
To ensure the integrity of the data collected within this organized system, several quality control measures were implemented:
Sample Size and Statistical Principles The study was powered to detect a 10% improvement in diagnostic accuracy.
For qualitative data, Fisher's exact or Chi-square tests were employed. Statistical significance was set at alpha = 0.05.
Safety and Ethical Standards The study complied with Regulation (EU) 2017/745 (MDR) and ISO 14155:2021. Data protection followed GDPR and Spanish Organic Law 3/2018, utilizing encrypted patient information and alphanumeric identification codes to maintain participant anonymity. All clinical data stored on the device is permanently deleted upon study conclusion.
496 studies on the registry are indexed under Skin Diseases; 77 are open to participants now.
This study's enrollment of 131 is below the median of 165 across 101 observational studies indexed under Skin Diseases.
Browse Skin Diseases studies →AI Labs Group S.L is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population is drawn from adult patients presenting with dermatological concerns at two primary care centers in the Madrid region: Centro de Salud de Majadahonda and Centro de Salud de Pozuelo. These participants are residents within the catchment areas of these clinics, with Hospital Universitario Puerta de Hierro Majadahonda serving as their reference hospital for specialized dermatology care.
The source population consists of individuals in a real-world clinical setting undergoing preliminary assessment by primary care practitioners (PCPs) for potential referral to specialized dermatology services. This diverse cohort is intended to represent a typical population affected by various skin pathologies, specifically including tumoral (benign and malignant), inflammatory, and infectious conditions.
Participants are identified and recruited during routine medical visits whenever a skin-related pathology is suspected.
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.
Exclusion Criteria:
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This single-group cohort comprises adult patients presenting with diverse skin pathologies who were evaluated by healthcare professionals (HCPs) using an AI-based clinical decision support tool. The cohort includes individuals suspected of having tumoral (benign or malignant), inflammatory, or infectious conditions.
Device: Primary care practitioners aided by Legit.Health Plus
The device is a computer vision software designed to assist healthcare practitioners in assessing skin structures through the analysis of digital images. Primary care practitioners utilize the device by capturing photographs of affected skin areas with a smartphone or mobile dermatoscope and uploading them to the platform. The software processes images of the epidermis and dermis to quantify visible clinical signs-including intensity, count, and extent-and provides an interpretive distribution of possible International Classification of Diseases (ICD) categories. Practitioners use the platform's results as a second medical opinion to guide diagnosis, triage, and referral decisions for pathologies including tumoral (benign and malignant), inflammatory, and infectious conditions. The intervention also provides clinicians with access to specific referral criteria, clinical questionnaires, and basic treatment
Referral appropriateness
This metric evaluates the appropriateness of patient referrals from primary care to specialized dermatology services. A referral is classified as "avoidable" or "unnecessary" when both the primary care practitioner and the expert dermatologist agree that the case can be effectively managed within primary care without a specialist consultation. The study's primary target for this metric was a minimum increase in referral adequacy of 15%. This threshold represents the minimum clinically important difference required to demonstrate the device's utility in optimizing clinical workflows and reducing healthcare costs.
Time frame: Baseline
Area Under the ROC Curve (AUC) for Malignancy Detection
This measure utilizes the Area Under the ROC Curve (AUC) to evaluate the device's discriminatory performance in differentiating between malignant lesions (including melanoma and basal cell carcinoma) and benign lesions. The AUC provides a comprehensive assessment of the tool's ability to correctly classify skin pathologies across various decision thresholds. The predefined acceptance criterion for this metric was an AUC $\\ge$ 80%. This threshold ensures that the device provides clinically meaningful support in identifying high-risk cases that require urgent specialist intervention.
Time frame: Baseline
Healthcare Professional Satisfaction (CUS Score)
Satisfaction is evaluated using the Clinical Utility and Satisfaction (CUS) Questionnaire. This validated assessment tool measures practitioners' perspectives on the device's diagnostic support, ease of use, data utility, and overall clinical applicability within their workflow. Results from the questionnaire are quantified either as a percentage of affirmative responses or as a mean score on a 10-point scale. This dual approach allows for both a qualitative understanding of practitioner consensus and a quantitative measure of perceived value.
Time frame: 4 months (practitioners completed the questionnaire twice: once at 2 months and again at 4 months after starting the study).
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jun 2022 to primary completion in Dec 2023, 17 months.
Of 54 observational studies under Skin Diseases, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 250. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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AI Labs Group S.L