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

Correlation of Dermatologist Made Biopsy Decisions With Artificial Intelligence (AI) Assisted Total Body Photography Detection of Outlier Lesions

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.

Study Overview

• Status: Completed
• Conditions: Skin Lesion
• Intervention / Treatment: Device: SkinIO

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 Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Halcyon Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Comparison of outlier analysis with dermatologist made biopsy decisions; Skin lesions recommended for skin biopsy by the dermatologist will be compared to lesions highlighted by the application outlier analysis.	Device: SkinIO; The device is simply an application that photographs skin lesions and identifies lesions that may require further examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatologist made biopsy decision compared to AI outlier lesions	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.	Three months

Collaborators and Investigators

• Sponsor: Halcyon Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 8, 2023

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Halc-1-ai

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes