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OpenTrials
Completed

NCT Number: NCT05940090

Correlation of Dermatologist Made Biopsy Decision With 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.

Completed

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Key information

Conditions

Skin Lesion

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Halcyon Dermatology

Laguna Hills, California, 92653, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SkinIO

Device

The device is simply an application that photographs skin lesions and identifies lesions that may require further examination

Primary outcomes

  1. Dermatologist made biopsy decision compared to AI outlier lesions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Halcyon Dermatology

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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