Correlation of Dermatologist Made Biopsy Decision With AI Assisted Total Body Photography Detection of Outlier Lesions

Completed

• Conditions: Skin Lesion
• Interventions: Device: SkinIO

• Registration Number: NCT05940090
• Lead Sponsor: Halcyon Dermatology

Brief Summary

This research study will determine how a smart phone application (app) for total body photography outlier analysis compares to a dermatologist's decision to biopsy skin lesions.

Detailed Description

Informed written consent will be obtained by all study subjects. Each participant will be asked to generate a unique identifier, so their demographic data, medical intake, and study assessments can be stored without any patient identifiers. The unique identifier is the participant's 2-digit day of birth, first 3 initials of their mother's maiden name, and the 4 digits of their birth year. All clinical data will be entered into a de- identified database.

Demographic information including age, gender, ethnicity, collected via medical intake survey at the initial visit. Data from the survey will be associated only with the patient's unique identifiers.

Study Timeline

• Study Start: 2023-07-03
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-11
• Status Verified: 2023-09
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-08
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Males and females participants in overall good health ages 18 to 85 who have skin lesions

Exclusion Criteria

• Those who are under 18 or over 85

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Comparison of outlier analysis with dermatologist made biopsy decisions	SkinIO	Skin lesions recommended for skin biopsy by the dermatologist will be compared to lesions highlighted by the application outlier analysis.

Primary Outcome Measures

Name	Time	Method
Dermatologist made biopsy decision compared to AI outlier lesions	Three months	Patient will undergo total body photography that marks outlier lesions. Without reviewing the photos, a dermatologist will make recommendations for which lesions should undergo skin biopsy.

Trial Locations

Locations (1)

Halcyon Dermatology; 🇺🇸 Laguna Hills, California, United States