A Skin Image Reference Tool to Aid Healthcare Providers' Diagnosis

NCT07033169 | Recruiting

• 1 other identifier: IRB00125043
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dermatologic Disease

Keywords

artificial intelligence; skin diseases; dermatology

Outcome Measures

Primary Outcomes (1)

• concordance of Belle.ai diagnoses with physician diagnoses.

  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.

  Day 1

Study Arms (1)

Patient at Advocate Health dermatology clinic

The study, subject recruitment, and analysis will be conducted within the Advocate Health system at Atrium Health Wake Forest Baptist (AHWFB) in Winston-Salem, NC. Recruiters for this study include Advocate Health dermatology attendings, fellows, and staff, who will capture images of patients presenting to Wake Forest Dermatology Clinics in Winston-Salem, NC.

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 400 participants will be recruited for this study

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• BelleTorus Corporation: collaborator

Study Sites (1)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Lindsay C Strowd, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irma M Richardson, MHA

CONTACT

336-716-2903; irichard@wakehealth.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (1)