Application of the Belle.AI Dermatological Image Reference System for Patient Diagnosis in an Active Clinical Setting

NCT06724627 | Recruiting DMC

• 2 other identifiers: 137662975N91023C00045
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Condition; Dermatology; Dermatology/Skin - Other

Keywords

AI; Artificial Intelligence; Digital Health; Health Equity; Dermatology; Skin Health

Outcome Measures

Primary Outcomes (2)

• Accuracy of Belle AI Image References

  Comparison of Belle AI's image reference system primary probability diagnosis to the reference diagnosis established by the dermatological review committee; additional evaluation of the accuracy of the second and third highest probability diagnoses determined by the Bell Image Match Score

  Through study completion, an average of 14 days

• Impact on Economic Burden

  Measure economic impact by enabling remote assessment for patients

  Through study completion, an average of 14 days

Secondary Outcomes (3)

• Agreement between diagnoses

  Through study completion, an average of 14 days

• Provider-Rated Usefulness

  Through study completion, an average of 14 days

• Cost-Impact Analysis

  Through study completion, an average of 14 days

Other Outcomes (1)

• Protocol Adherence

  Through study completion, an average of 14 days

Study Arms (1)

Standard of care

OTHER

Standard of care

Diagnostic Test: Dermatology/Skin - Other

Interventions

Dermatology/Skin - Other DIAGNOSTIC_TEST

Belle AI for skin image assessment.

Standard of care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must present to walk-in clinic with a primary dermatological complaint.
• Patient must have the ability and willingness to provide informed consent and comply with study procedures and visits.
• Participants must have access to the required technology (e.g., smartphone with internet access) and be capable of using it for the required image capture.

You may not qualify if:

• Patients who are unable to comply with study procedures due to physical or mental health limitations (as assessed by study coordinator).
• Pediatric, adolescent, and teen patients who present with dermatological conditions on their genitalia will not be included in the study (in support of patient privacy concerns).

Sponsors & Collaborators

• BelleTorus Corporation: lead
• Urban Health Plan Inc.: collaborator

Study Sites (1)

Urban Health Plan Inc.

The Bronx, New York, 07059, United States

RECRUITING

Related Links

• AI for skin image assessment
• Bronx, Queens and Harlem-based clinics serving 90,000 patients

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• John Romano, MD

  BelleTorus Corporation

  PRINCIPAL INVESTIGATOR

• Franco Barsanti, PharmD

  Urban Health Plan Inc.

  STUDY DIRECTOR

Central Study Contacts

John Romano, MD

CONTACT

617-520-4730; jromano@belle.ai

Franco Barsanti, PharmD

CONTACT

347-446-0227; franco.barsanti@urbanhealthplan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three independent dermatologists set the gold standard diagnosis by reviewing skin image capture by primary care providers using smartphone cameras. Study will measure how primary care providers move closer to the gold standards with the support of AI image assessment. The study also measures impact on health equity by enabling at-home, remote assessment of skin images captured by patient smartphones, followed by assessment of AI for provider review.

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: December 9, 2024
• Study Start: September 16, 2024
• Primary Completion: March 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)