Recruiting

AI Dermatological Image System for Primary Care Providers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Dermatology/Skin - Other

Diagnostic Test
Who is being recruted

Skin Diseases

+ Skin and Connective Tissue Diseases

+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: September 2024
See protocol details

Summary

Principal SponsorBelleTorus Corporation
Study ContactJohn Romano, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 16, 2024

Actual date on which the first participant was enrolled.

This study is investigating the use of an AI tool called Belle AI in helping doctors who are not skin specialists diagnose skin conditions. Often, people with skin issues see general doctors, not dermatologists, due to limited access to specialists. This can sometimes lead to less accurate diagnoses. The AI tool is designed to improve these diagnoses by analyzing images of skin conditions and providing advice on what the condition might be. The hope is that this will help doctors make better decisions, save money, and improve patient care. In the study, participants will use a smartphone app to take pictures of their skin problems, which the AI tool will then analyze. Doctors will look at the AI's suggestions and compare them to their own diagnoses. Participants will be asked to submit images again after a few weeks, and follow-up appointments might be scheduled based on the AI's analysis. Participants who help by submitting images are offered financial incentives. The study also ensures privacy by using a special code linked to each participant's health records. Throughout this process, experienced dermatologists will review the cases to confirm the final diagnosis.

Official TitleApplication of the Belle.AI Dermatological Image Reference System on Patient Diagnosis Within an Active Clinical Setting
NCT06724627
Principal SponsorBelleTorus Corporation
Study ContactJohn Romano, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

263 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Skin DiseasesSkin and Connective Tissue Diseases

Criteria

3 inclusion criteria required to participate
Patient must present to walk-in clinic with a primary dermatological complaint.

Patient must have the ability and willingness to provide informed consent and comply with study procedures and visits.

Participants must have access to the required technology (e.g., smartphone with internet access) and be capable of using it for the required image capture.

2 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Standard of care

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Urban Health Plan Inc.

The Bronx, United StatesOpen Urban Health Plan Inc. in Google Maps
Recruiting
One Study Center