Clinical Trial

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

Study acronym: LegitHealth PH
Completed
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07428941
Lead Sponsor AI Labs Group S.L
Collaborators: Puerta de Hierro University Hospital
Conditions Skin Lesions, Melanocytic Nevi, Melanoma (Skin Cancer), Basal Cell Carcinoma of Skin, Urticaria, Pustular Psoriasis, Actinic Keratoses, Plaque Psoriasis +1 more
Enrollment 9 participants
Start Date 2024-06-04
Primary Completion 2024-09-13 (estimated)
Study Completion 2024-09-13 (estimated)
Updated on ClinicalTrials.gov 2026-02-24