AI Tool for Skin Conditions
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this research study is to test a new, investigational tool that uses artificial intelligence (AI) to help primary care providers assess skin conditions. This tool is an AI-powered dermatology image reference app that works with a smartphone. For clarity, the AI makes no diagnoses; it provides reference images. Primary care providers then use their own medical judgement and training to make the diagnosis.The sponsor aims to compare the diagnoses made by primary care providers (such as doctors, nurse practitioners, and physician assistants) with the support of the AI tool compared to a panel of dermatologists, who are setting the gold standard. By doing so, the sponsor can determine the value of the AI tool for primary care providers and understand how it might be used alongside traditional clinical care.This AI capability complies with FDA regulatory guidelines and is not considered a medical device, similar to a Google image search, which returns similar looking images for reference purposes. For intervention, they healthcare providers use their own training and clinical judgement to make the diagnosis, and not the AI.
Who Is on the Research Team?
John Romano, MD
Principal Investigator
BelleTorus Corporation
Franco Barsanti, PharmD
Principal Investigator
Urban Health Plan Inc.
Are You a Good Fit for This Trial?
This trial is for primary care providers who diagnose skin conditions. It's designed to see if an AI-powered dermatology image reference app can help them in their assessments. Providers must use their medical judgement, not the AI, to make diagnoses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Consultation
Participants have an initial appointment where providers examine the patient, document their history, and diagnose the condition. The BellePro Physician App is used to capture images and generate a differential diagnosis.
Image Submission and AI Analysis
Participants submit images using the app starting seven days after enrollment. Providers reassess the diagnosis using updated AI analysis.
Follow-up
Participants are monitored for diagnostic accuracy and utility of the AI tool. A follow-up appointment is scheduled two weeks after the initial consultation.
What Are the Treatments Tested in This Trial?
Find a Clinic Near You
Who Is Running the Clinical Trial?
BelleTorus Corporation
Lead Sponsor
Urban Health Plan Inc.
Collaborator