At-Home Dermoscopy Artificial Intelligence

At-Home Dermoscopy Artificial Intelligence for Optimizing Early Triage of Skin Cancers and Atypical Melanocytic Nevi With Uncertain Malignant Potential

This is a new protocol to analyze how the use of the Sklip System enables laypersons to safely triage self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified performance goals for the detection of PSLCs that require biopsy (Melanoma and atypical melanocytic nevi with uncertain malignant, Squamous cell carcinoma, Basal cell carcinoma).

The study protocol will also compare the accuracy of the Sklip System when used by a layperson (Participant) versus near-perfect Sklip System user (Study Coordinator), assess whether Sklip System improves triage of PSLCs < 6 mm in diameter and triage of thin melanomas with <0.8 mm Breslow depth as suspicious, as compared to the current medical provider virtual triage method that relies on store-and-forward of smartphone clinical images (SCI), and assess accuracy of layperson-performed self-skin-exams (SSEs) at-home in the identification of all suspicious PSLCs present on their body as compared to the same layperson (Participant) evaluated with a full body skin examination (FBSE) by a dermatology Provider (DP) in-person.

Study Overview

• Status: Terminated
• Conditions: Malignant Skin Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Dermoscopy; Other: Digital Photography; Procedure: Self-Skin Examination; Device: Skin Examination with Sklip; Procedure: Skin Examination

Detailed Description

PRIMARY OBJECTIVE:

I. The Sklip System enables laypersons to safely triage self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified performance goals* for detection of PSLCs that require biopsy and are malignant: Melanoma and atypical melanocytic nevi with uncertain malignant potential (moderate, severe, and high grade atypia; those with pathology reports that include notes such as: borderline, cannot exclude melanoma, cannot exclude early evolving melanoma, unusual features, atypical spitz nevi, suspicion for melanoma, re-excision (or further removal) should be considered or is recommended in the pathologist management comment) (≥95% sensitivity, ≥30% specificity), Squamous cell carcinoma (≥80% sensitivity, ≥30% specificity), Basal cell carcinoma (≥80% sensitivity, ≥30% specificity).

EXPLORATORY OBJECTIVES:

I. To compare the accuracy of Sklip System triage when used by a layperson versus near-perfect Sklip System user II. To assess whether Sklip System improves triage of pigmented skin lesions of concern < 6mm in diameter as suspicious as compared to the current medical provider virtual triage method that relies on store-and-forward non-medical-device assisted smartphone clinical images III. To assess whether Sklip System improves triage of thin melanomas with < 0.8 mm Breslow depth as suspicious as compared to the current medical provider virtual triage method that relies on store-and-forward non-medical-device assisted smartphone clinical images IV. To determine the accuracy of layperson-performed self-skin-exam(s) at-home in the identification of all suspicious pigmented skin lesions of concern present on their body as compared to the same layperson evaluated with full body skin examination by a dermatology Provider in-office

OUTLINE:

This is a single-arm prospective trial. Participants perform self-skin exams using naked-eye criteria and will take smartphone clinical images (SCI) of each PSL of concern (PSLC). Participants will also take digital dermoscopy images (DDIs) and apply the Sklip System to each PSLC of concern in up to 14 days. Within up to 28 days of completing the at-home exams, participants will undergo an in-office visit full body skin exam (FBSE).

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant or legally authorized representative (LAR) must provide written informed consent before any Study-specific procedures or interventions are performed.
2. Age ≥ 21 years with at least one pigmented skin lesion (PSL)/mole on their body. All genders and members of all races and ethnic groups will be included.
3. Participant self-identifies as having Fitzpatrick Skin Type 1 through 4.
4. Participant must be a current or new patient through self-referral or Provider-referral at the participating Study Site.
5. Participant must have access to a smartphone/tablet and be willing to set up virtual communication via direct message to a Study Site dermatology provider (i.e. MyChart in EPIC, direct message in ModMed EMA or other electronic medical record (EMR) type)
6. Participant must be English-speaking due to FDA Breakthrough Designation of the Sklip System in the English language. Therefore, we are unable to accommodate non-English speaking Participants.
7. Participant must be "Healthy", which is defined as someone considered not urgently sick or hospitalized. This will be determined by the Study principle investigator (PI) at each Study Site, a licensed dermatologist, who will be responsible for screening Participants to ensure eligibility criteria is met prior to enrollment.

Exclusion Criteria:

1. Participant who self-identifies having Fitzpatrick Skin Type 5 or 6.
2. Participant who have had a skin check visit with a dermatology Provider within the last 90 days will be excluded to avoid self-selection bias, unless the Participant identifies a new unexamined (not previously documented) spot of concern.
3. Vulnerable populations including children, prisoners, and decisional impaired adults as well as vision impaired adults will not be eligible for this Study.
4. Pregnant individuals will be excluded in this Study. Since this is a minimal pregnancy risk category, no special precautions will be taken to determine that the patient is not pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Self-skin exam (SSE), digital dermoscopy image (DDI), Sklip System, full body skin exam (FBSE).; This is a single-arm prospective trial. Participants perform self-skin exams using naked-eye criteria and will take smartphone clinical images (SCI) of each PSL of concern (PSLC). Participants will also take digital dermoscopy images (DDIs) and apply the Sklip System (integrating the Sklip Mole Scan Algorithm (SMSA) to each PSLC of concern in up to 14 days. Within up to 28 days of completing the at-home exams, participants will undergo an in-office visit full body skin exam (FBSE).

Other: Survey Administration; Ancillary studies; Other: Dermoscopy; Take digital dermoscopy images (DDI); Other Names: dermoscopic image; Other: Digital Photography; Take smartphone clinical images (SCI); Other Names: Clinical image; Procedure: Self-Skin Examination; Perform self-skin exam (SSE); Other Names: skin exam; Device: Skin Examination with Sklip; Apply Sklip System; Other Names: Sklip Mole Scan Algorithm (SMSA); Procedure: Skin Examination; Undergo in-person full body skin examination (FBSE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triage Accuracy of the Sklip System Using Participant At-home Digital Dermoscopy Image (DDI)	To analyze layperson Sklip System triage of self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified performance goals for detection of PSLCs that require biopsy and are malignant: Melanoma and atypical melanocytic nevi with uncertain malignant potential (moderate, severe, and high grade atypia; those with pathology reports that include notes such as: borderline, cannot exclude melanoma, cannot exclude early evolving melanoma, unusual features, atypical spitz nevi, suspicion for melanoma, re-excision (or further removal) should be considered or is recommended in the pathologist management comment) (≥95% sensitivity, ≥30% specificity), Squamous cell carcinoma (≥80% sensitivity, ≥30% specificity), Basal cell carcinoma (≥80% sensitivity, ≥30% specificity). Two-sided 95% confidence intervals for all Sensitivities and Specificities will be calculated using the Exact (Clopper-Pearson) method.	From first day of enrollment to 42 days after first day of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of suspicious lesions identified	The total number of suspicious lesions identified in both groups at the end of 4 months. All suspicious lesions will be reviewed by an expert dermoscopist(s) to determine how many were correctly identified as qualified for triage number needed to triage (NNT).	Up to 4 months after first day of enrollment
Total number of biopsied lesions	All properly qualified suspicious lesions will be compared to final pathology reports, the denominator being a diagnosis of atypical nevus, melanoma in-situ, melanoma, or non-melanoma skin cancer. Sensitivity of correct triage will be determined by using any of the above pathology diagnosis (excluding a benign melanocytic nevus without the word atypical or unusual in the diagnosis title).	Up to 4 months after first day of enrollment
Average diameter of correctly biopsied lesions	The number of atypical nevi, melanoma in-situ, melanoma and non-melanoma skin cancer with a diameter < 6 mm will be used as a success measure. Will be estimated with two-sided 95% confidence intervals, and compared using a two-sample t-test.	Up to 4 months after first day of enrollment
Average Breslow depth of biopsied melanomas	The average Breslow depth of biopsied melanomas in both groups at the end of 4 months. Will be estimated with two-sided 95% confidence intervals, and compared using a two-sample t-test.	Up to 4 months after first day of enrollment

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Sancy A. Leachman, MD, PhD, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Neoplasms; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Microscopy; Intravital Microscopy; Dermoscopy
• Other Study ID Numbers: STUDY00023727 (Other Identifier: OHSU Knight Cancer Institute); NCI-2021-13411 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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.: No