Actively Recruiting
A Skin Image Reference Tool to Aid Healthcare Providers' Diagnosis of Commonly Encountered Dermatologic Diseases
Led by Wake Forest University Health Sciences · Updated on 2025-10-24
400
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
B
BelleTorus Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the accuracy of the Belle.ai software in diagnosing common dermatologic diseases across different skin tones. The software uses deep learning technology to analyze clinical images of skin conditions and provides a differential diagnosis from a database of over 2,000 skin conditions based on more than 500,000 images. The study will determine how well the AI-generated diagnoses match those of dermatology experts. Participants who consent will have three images taken of their skin condition using the Belle.ai software. These images will be de-identified and uploaded into the system, where the software will generate a single list of possible diagnoses. Dermatology experts will then review the cases to compare their diagnoses with the AI results. The study will be conducted at dermatology clinics within the Advocate Health system. During the study, images will be captured and uploaded securely without any personal identifiers. The Dermatologic Review Committee will assess the concordance between the AI's primary diagnosis and expert opinions, aiming for greater than 80% agreement. Participants will not need to complete any additional forms, and their involvement primarily involves image capture during their clinic visit. The main outcome measured is the agreement between AI and physician diagnoses on the day of image capture.
CONDITIONS
Brief Title
A Skin Image Reference Tool to Aid Healthcare Providers' Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must present to an Advocate Health dermatology clinic
- Patient must have the ability and willingness to provide informed consent and comply with study procedures and visits
- Participant dermatologists must have access to the required technology (e.g., smartphone with internet access) and be capable of using it for the required image capture
- Participants must be 10 years of age or older
You will not qualify if you...
- 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 to support patient privacy concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
Participants have three images taken of their dermatologic disease which are uploaded to the Belle.ai software for AI-generated diagnosis.
1 visit (in-person)
Duration - Up to study completion in December 2027
Dermatology experts review and adjudicate the AI-generated diagnoses for concordance over time.
Follow-up assessments as needed
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
I
Irma M Richardson, MHA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here