NCT05940090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2023

Completed
Last Updated

February 28, 2024

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

July 3, 2023

Last Update Submit

February 26, 2024

Conditions

Skin Lesion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

SkinIODEVICE

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

Comparison of outlier analysis with dermatologist made biopsy decisions

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Those who are under 18 or over 85

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halcyon Dermatology

Laguna Hills, California, 92653, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 11, 2023

Study Start

July 3, 2023

Primary Completion

October 1, 2023

Study Completion

October 8, 2023

Last Updated

February 28, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)