Malignant Skin NeoplasmNCT05321784

At-Home Dermoscopy Artificial Intelligence

A study testing Dermoscopy, Digital Photography and Self-Skin Examination in people with Malignant Skin Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Malignant Skin Neoplasm
What is being tested?: Dermoscopy, Digital Photography and Self-Skin Examination
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 27 Sep 2023to 30 Sep 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant or legally authorized representative (LAR) must provide written informed consent before any Study-specific procedures or interventions are performed.
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.
Participant self-identifies as having Fitzpatrick Skin Type 1 through 4.
Participant must be a current or new patient through self-referral or Provider-referral at the participating Study Site.
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)
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.
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.

Who cannot join

Participant who self-identifies having Fitzpatrick Skin Type 5 or 6.
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.
Vulnerable populations including children, prisoners, and decisional impaired adults as well as vision impaired adults will not be eligible for this Study.
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

Trial locations and contacts

1 site in 1 country.

United States1 site

OHSU Knight Cancer Institute
Portland, Oregon, 97239

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

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:

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).

Conditions: Malignant Skin Neoplasm
Being tested: Dermoscopy, Digital Photography, Self-Skin Examination, Skin Examination with Sklip, Skin Examination
Medical subject headings: Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DermoscopyOther
Also called dermoscopic image
Take digital dermoscopy images (DDI)
Digital PhotographyOther
Also called Clinical image
Take smartphone clinical images (SCI)
Self-Skin ExaminationProcedure or surgery
Also called skin exam
Perform self-skin exam (SSE)
Skin Examination with SklipDevice
Also called Sklip Mole Scan Algorithm (SMSA)
Apply Sklip System
Skin ExaminationProcedure or surgery
Undergo in-person full body skin examination (FBSE)
Survey AdministrationOther
Ancillary studies

Study groups in NCT05321784
Study group	Role	What they receive
Self-skin exam (SSE), digital dermoscopy image (DDI), Sklip System, full body skin exam (FBSE).	Experimental	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). Receives: Other: Dermoscopy; Other: Digital Photography; Procedure: Self-Skin Examination; Device: Skin Examination with Sklip; Procedure: Skin Examination; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From first day of enrollment to 42 days after first day of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 202330 Sep 2024

First posted11 Apr 2022
Study start27 Sep 2023
Primary completion30 Sep 2024
Study completion30 Sep 2024

Why it stopped: Inadequate enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Malignant Skin NeoplasmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05321784
Sponsor's protocol ID: STUDY00023727
Other IDs: NCI-2021-13411, STUDY00023727
Status last verified: Dec 2025
First submitted: 1 Apr 2022
Last updated: 29 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malignant Skin Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: At-Home Dermoscopy Artificial Intelligence for Optimizing Early Triage of Skin Cancers and Atypical Melanocytic Nevi With Uncertain Malignant Potential
ClinicalTrials.gov ID: NCT05321784
Acronym / sponsor ID: STUDY00023727
Conditions: Malignant Skin Neoplasm
Study type: Interventional
Recruitment status: TerminatedReason stopped: Inadequate enrollment
Enrolment: 1 participants (actual)
Lead sponsor: OHSU Knight Cancer InstituteUniversity, hospital or other
Collaborators: Oregon Health and Science University
Study start: 27 Sep 2023 (actual)
Primary completion: 30 Sep 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 11 Apr 2022 (actual)
Results: Posted 29 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

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:

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:

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Self-skin exam (SSE), digital dermoscopy image (DDI), Sklip System, full body skin exam (FBSE).	Experimental	Other: Dermoscopy, Other: Digital Photography, Procedure: Self-Skin Examination, Device: Skin Examination with Sklip, Procedure: Skin Examination, Other: Survey AdministrationThis 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).

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Participant or legally authorized representative (LAR) must provide written informed consent before any Study-specific procedures or interventions are performed.
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.
Participant self-identifies as having Fitzpatrick Skin Type 1 through 4.
Participant must be a current or new patient through self-referral or Provider-referral at the participating Study Site.
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)

Key exclusion criteria (4 listed)

Participant who self-identifies having Fitzpatrick Skin Type 5 or 6.
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.
Vulnerable populations including children, prisoners, and decisional impaired adults as well as vision impaired adults will not be eligible for this Study.
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DermoscopyAlso: dermoscopic imageTake digital dermoscopy images (DDI)	Other	Self-skin exam (SSE), digital dermoscopy image (DDI), Sklip System, full body skin exam (FBSE).
Digital PhotographyAlso: Clinical imageTake smartphone clinical images (SCI)	Other	Self-skin exam (SSE), digital dermoscopy image (DDI), Sklip System, full body skin exam (FBSE).
Self-Skin ExaminationAlso: skin examPerform self-skin exam (SSE)	Procedure or surgery	Self-skin exam (SSE), digital dermoscopy image (DDI), Sklip System, full body skin exam (FBSE).
Skin Examination with SklipAlso: Sklip Mole Scan Algorithm (SMSA)Apply Sklip System	Device	Self-skin exam (SSE), digital dermoscopy image (DDI), Sklip System, full body skin exam (FBSE).
Skin ExaminationUndergo in-person full body skin examination (FBSE)	Procedure or surgery	Self-skin exam (SSE), digital dermoscopy image (DDI), Sklip System, full body skin exam (FBSE).
Survey AdministrationAncillary studies	Other	Self-skin exam (SSE), digital dermoscopy image (DDI), Sklip System, full body skin exam (FBSE).

Primary outcome

Triage Accuracy of the Sklip System Using Participant At-home Digital Dermoscopy Image (DDI)
Time frame: From first day of enrollment to 42 days after first day of enrollment
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.

Results and safety

Results posted to the registry on 29 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Self-skin Exam (SSE), Digital Dermoscopy Image (DDI), Sklip System, Full Body Skin Exam (FBSE).	1	0

Primary outcome: Triage Accuracy of the Sklip System Using Participant At-home Digital Dermoscopy Image (DDI)

Time frame: From first day of enrollment to 42 days after first day of enrollment

Population analysed: No data was collected for this outcome due to incomplete participation.

Adverse events

Time frame: Participants are monitored 28 days following their conclusion of both study phases to account for any relevant data that may have not been collected during the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Self-skin Exam (SSE), Digital Dermoscopy Image (DDI), Sklip System, Full Body Skin Exam (FBSE).	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): Insufficient data collected to analyze outcomes due to low enrollment

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sancy A. Leachman, MD, PhD principal investigator

OHSU Knight Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dermoscopy, Digital Photography and Self-Skin Examination in people with Malignant Skin Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Triage Accuracy of the Sklip System Using Participant At-home Digital Dermoscopy Image (DDI) (time frame: From first day of enrollment to 42 days after first day of enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05321784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.