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NCT Number: NCT07033169

A Skin Image Reference Tool to Aid Healthcare Providers' Diagnosis

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

Recruiting

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Chenan Huang, MD

CONTACT

[email protected]

321-948-1368

Lindsay C Strowd, MD,

PRINCIPAL_INVESTIGATOR

irma M Richardson, MHA

CONTACT

[email protected]

336-716-2903

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. concordance of Belle.ai diagnoses with physician diagnoses.

    Time frame: Day 1

    The study coordinator will review uploaded patient "cases" and assign them for review and adjudication to designated Dermatologic Review Committee (DRC) members within the Belle web portal. The DRC will be comprised of 1-2 Advocate Health board-certified dermatologists from each of the Winston, Charlotte, and Midwest dermatology practices.

Study contacts

Contact information is provided by the study sponsor or research team.

Irma M Richardson, MHA

CONTACT

[email protected]

336-716-2903

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • BelleTorus Corporation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2025
Registry last updated
Oct 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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