Using AI to help diagnose skin conditions in primary care
Application of the Belle.AI Dermatological Image Reference System on Patient Diagnosis Within an Active Clinical Setting
NA · BelleTorus Corporation · NCT06724627
This study is testing an AI app that helps primary care doctors diagnose skin conditions more accurately by comparing their findings to a panel of dermatologists.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 263 (estimated) |
| Sex | All |
| Sponsor | BelleTorus Corporation (industry) |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06724627 on ClinicalTrials.gov |
What this trial studies
This research evaluates an AI-powered dermatology image reference app designed to assist primary care providers in diagnosing skin conditions. The app provides reference images based on a convolutional neural network trained on over 500,000 images, allowing providers to compare their assessments with a panel of dermatologists. The study aims to determine the effectiveness of this tool in enhancing diagnostic accuracy for non-specialists in real-time clinical settings. By comparing diagnoses made with and without the AI tool, the research seeks to understand its potential role in improving patient care.
Who should consider this trial
Good fit: Ideal candidates are patients presenting with primary dermatological complaints at walk-in clinics who can provide informed consent and use the required technology.
Not a fit: Patients with physical or mental health limitations that prevent compliance with study procedures, as well as pediatric patients with genital dermatological conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could significantly enhance the diagnostic accuracy of primary care providers, leading to better patient outcomes for skin conditions.
How similar studies have performed: Previous studies have shown that AI tools can enhance diagnostic accuracy for dermatological conditions, particularly for non-specialists, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Where this trial is running
The Bronx, New York
- Urban Health Plan Inc. — The Bronx, New York, United States (RECRUITING)
Study contacts
- Principal investigator: John Romano, MD — BelleTorus Corporation
- Study coordinator: John Romano, MD
- Email: jromano@belle.ai
- Phone: 617-520-4730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Skin Condition, Dermatology, Dermatology/Skin - Other, AI, Artificial Intelligence, Digital Health, Health Equity, Skin Health