263 Participants Needed

AI Tool for Skin Conditions

JR
FB
Overseen ByFranco Barsanti, PharmD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: BelleTorus Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

Research Team

JR

John Romano, MD

Principal Investigator

BelleTorus Corporation

FB

Franco Barsanti, PharmD

Principal Investigator

Urban Health Plan Inc.

Eligibility Criteria

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

Patient must have the ability and willingness to provide informed consent and comply with study procedures and visits
I am visiting the clinic for a skin-related issue.
I have a smartphone with internet and can use it to take pictures.

Exclusion Criteria

Patients who are unable to comply with study procedures due to physical or mental health limitations (as assessed by study coordinator)
I am under 18 and do not have skin conditions on my genital area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

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.

1 day
1 visit (in-person)

Image Submission and AI Analysis

Participants submit images using the app starting seven days after enrollment. Providers reassess the diagnosis using updated AI analysis.

7-14 days
Remote image submissions

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.

2-4 days
1 visit (in-person or virtual)

Treatment Details

Trial Overview The study tests an investigational AI tool that provides reference images of skin conditions via a smartphone app. The effectiveness of this tool will be compared with the diagnosis accuracy of expert dermatologists.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Standard of careExperimental Treatment1 Intervention
Standard of care

Find a Clinic Near You

Who Is Running the Clinical Trial?

BelleTorus Corporation

Lead Sponsor

Trials
1
Recruited
260+

Urban Health Plan Inc.

Collaborator

Trials
1
Recruited
260+
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