Clinical trial · Observational
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
A Project to Enhance Dermatology E-consultations in Primary Care Centers Using Artificial Intelligence Tools.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Skin Abnormalities | — | UNRESOLVED | — |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Skin Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Primary care practitioners aided by Legit.Health Plus | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patiens with skin conditions treated in Primary care
- description
- 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.
- interventionNames
- Device: Primary care practitioners aided by Legit.Health Plus
Primary outcomes (1)
- measure
- Referral appropriateness
- timeFrame
- Baseline
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Tumor pathology: * Benign: * Histiocytoma * Seborrheic keratosis * Angiomas * Precancerous: * Actinic keratosis * Suspected malignancy: * Basal cell carcinoma * Squamous cell carcinoma * Pigmented lesions: * Melanocytic nevus * Malignant melanoma * Inflammatory pathology: * Psoriasis * Atopic dermatitis * Urticaria * Hidradenitis suppurativa * Lichen planus * Infectious pathology: * Viral warts * Molluscs * Herpes simplex * Patients aged 18 years or older. * Patients who have signed the informed consent for the study. Exclusion Criteria: * Patients under 18 years of age. * Pregnant patients. * Patients who, in the opinion of the researcher, will not comply with the study procedures.
References
Publications (0)
Data not yet available