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Evaluating an Artificial Intelligence Tool to Help Primary Care Doctors Diagnose Skin Conditions.

NCT07428941 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2026-02-24

No results posted yet for this study

Summary

This study aims to determine if an artificial intelligence (AI) medical device can help primary care doctors more accurately identify and manage various skin conditions. Skin issues are a frequent reason for doctor visits, but differences in expertise between general practitioners and specialists can sometimes lead to misdiagnoses or unnecessary referrals.

The researchers hypothesized that the information provided by the AI device would increase the true diagnostic accuracy of primary care practitioners for multiple dermatological conditions. To test this, the study followed a prospective, self-controlled design where each participating doctor served as their own comparison.

During the study, 9 primary care physicians evaluated 30 clinical images representing a variety of skin pathologies. For each image, the doctors followed a two-step process:

* First, they provided a diagnosis based only on the image and the patient's medical history.
* Second, they were shown the AI's analysis-including the top 5 suggested diagnoses and confidence levels-and asked to provide a final diagnosis.

The study also investigated if the AI could help doctors decide whether a patient truly needs a referral to a specialist or if the condition could be handled remotely via teledermatology. The primary question was whether using this AI support would significantly increase the number of correct diagnoses made by primary care doctors and lead to more efficient patient care.

Conditions

  • Skin Lesions
  • Melanocytic Nevi
  • Melanoma (Skin Cancer)
  • Basal Cell Carcinoma of Skin
  • Urticaria
  • Pustular Psoriasis
  • Actinic Keratoses
  • Plaque Psoriasis
  • Hidradenitis Suppurativa (HS)

Interventions

DEVICE

AI-based medical device for aided diagnosis in dermatological conditions

The intervention consists of a Computer-Aided Diagnosis (CAD) software-only medical device that utilizes computer vision algorithms to analyze digital images of skin structures. During the study, healthcare professionals use the tool as a diagnostic support system to assist in the evaluation of complex dermatological conditions.

Sponsors & Collaborators

  • Puerta de Hierro University Hospital

    collaborator OTHER

  • AI Labs Group S.L

    lead INDUSTRY

Principal Investigators

  • Antonio Martorell, PhD · Hospital Universitari de Manises

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2024-09-13
Completion
2024-09-13

Countries

  • Spain

Study Locations

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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 NCT07428941 on ClinicalTrials.gov