A Skin Image Reference Tool to Aid Healthcare Providers'... | NCT07033169

Studies
A Skin Image Reference Tool to Aid Healthcare Providers' Diagnosis

NCT07033169

Sponsor

Wake Forest University Health Sciences

Status

Recruiting

Last Update Posted

Oct 24, 2025Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Dermatologic Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2025Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Jun 13, 2025

First Submission Date that Met QC Criteria

Jun 13, 2025

First Posted Date

Jun 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2025

Last Update Posted Date

Oct 24, 2025Actual

Name	Class
BelleTorus Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Up to 400 participants will be recruited for this study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Irma M Richardson, MHA	Contact	336-716-2903		irichard@wakehealth.edu

Overall Officials

Name	Affiliation	Role
Lindsay C Strowd, MD	Wake Forest University Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wake Forest University Health Sciences Department of Dermatology	Recruiting	Winston-Salem	North Carolina	27157	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The 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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012871	Skin Diseases

Ancestor Terms

ID	Term
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided