MedTrace Logo

Using an Artificial Intelligence Medical Device to Help Primary Care Practitioners Identify and Manage Skin Conditions (Tumor, Inflammatory, and Infectious Diseases) in Adult Patients at Pozuelo and Majadahonda Health Centers

NCT07429123 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 131

Last updated 2026-02-24

No results posted yet for this study

Summary

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:

* Does using the AI tool help doctors make more accurate diagnoses for multiple skin conditions?
* Does the tool help doctors better decide which patients need a referral to a dermatologist and which can be managed in primary care?
* Are doctors satisfied with how well the tool works and how easy it is to use in their daily work?
* Can the tool help doctors more accurately differentiate between benign lesions and skin cancer?

Participants will:

* Visit their primary care doctor for a regular skin checkup.
* Have photos taken of their skin condition using a smartphone or a dermatoscope.
* Provide informed consent for their photos and basic health information (such as age and sex) to be analyzed by the AI tool.
* Receive standard care from their doctor, with the tool providing a second opinion to assist in the clinical decision-making process.

Conditions

  • Skin Condition
  • Skin Abnormalities
  • Malignancy
  • Melanoma (Skin Cancer)
  • Skin Cancer

Interventions

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

Sponsors & Collaborators

  • Fundación para la Investigación Biomédica, Hospital Universitario Puerta de Hierro

    collaborator UNKNOWN

  • Puerta de Hierro University Hospital

    collaborator OTHER

  • AI Labs Group S.L

    lead INDUSTRY

Principal Investigators

  • Gaston Roustan, PhD · Puerta de Hierro Majadahonda University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-24
Primary Completion
2023-12-19
Completion
2024-01-10

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07429123 on ClinicalTrials.gov