A Skin Image Reference Tool to Aid Healthcare Providers' Diagnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dermatologic Disease. Basic parameters: from 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Skin Image Reference Tool to Aid Healthcare Providers' Diagnosis of Commonly Encountered Dermatologic Diseases
Overview
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.
Primary outcome measures
- concordance of Belle.ai diagnoses with physician diagnoses. [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- 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
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Wake Forest University Health Sciences Department of Dermatology — Winston-Salem
Identifiers
NCT: NCT07033169 · IRB00125043