NCT07033169

A Skin Image Reference Tool to Aid Healthcare Providers' Diagnosis

A Skin Image Reference Tool to Aid Healthcare Providers' Diagnosis of Commonly Encountered Dermatologic Diseases

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: —

Summary

Consented patients will have three images taken of their dermatologic conditions within the Belle.ai software. These images will be uploaded and saved within the Belle software system where a single AI-generated differential list will be generated based on the three photos. All photos uploaded will be de-identified. The software will not have any unique identifiers of participants saved in the system. The photos will be named based on participant enrollment numbers or unique code numbers and no unique identifiers will be attached to the photos. There will be no data collection form necessary for this study

Detailed description

Belle.ai provides a differential diagnosis from more than 2,000 different skin conditions leveraging a database trained on over 500,000 images. The image referencing technology deploys deep learning to analyze an uploaded clinical image and then matches its geometric pattern characteristics to Belle.ai's database of images to provide reference differentials. The purpose is to determine the validity of the Belle.ai software in diagnosing common dermatologic diseases across a range of skin tones. Consented patients will have three images taken of their dermatologic disease within the Belle.ai software. These images will be uploaded and saved within the Belle system where a single AI-generated differential list will be generated based on the three photos. The study coordinator will review uploaded patient "cases" and assign the cases for review and adjudication to designated Dermatologic Review Committee (DRC) members within the Belle web portal. Successful validation will require \>80% concordance between Belle.ai's primary working diagnosis (#1 on the differential) and our dermatology experts. A team of dermatology experts will then secondarily assess the concordance among the remaining diagnoses.

Conditions

• Dermatologic Disease

Timeline

• Start date: 2025-09-15
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2025-06-24
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States