Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07033169

Conditions

Dermatologic Disease

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07033169

Start date

Sep 15, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • concordance of Belle.ai diagnoses with physician diagnoses. [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Irma M Richardson, MHA

336-716-2903irichard@wakehealth.edu

Locations

Wake Forest University Health Sciences Department of Dermatology

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Chenan Huang, MD

321-948-1368Chenan.Huang@advocatehealth.org

irma M Richardson, MHA

336-716-2903irma.richardson@advocatehealth.org

Principal Investigator:

Lindsay C Strowd, MD,

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Keywords

  • artificial intelligence
  • skin diseases
  • dermatology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2025-10-24.