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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05940090
Enrollment
23
Registered
2023-07-11
Start date
2023-07-03
Completion date
2023-10-08
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Lesion

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.

Interventions

DEVICESkinIO

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

Sponsors

Halcyon Dermatology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Dermatologist made biopsy decision compared to AI outlier lesionsThree monthsPatient 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026