[Trial of device that is not approved or cleared by the U.S. FDA]

October 5, 2025 updated by: [Redacted]
The TruScore AI algorithm is currently in the learning training data stage of development. Therefore, the TruScore assessments made in this study will train the TruScore AI algorithm to produce a probabilistic measure of malignancy level.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withheld

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Veriskin, Inc. is developing the TruScore, a non-invasive, low-cost, hand-held device that aids both non-expert clinicians and dermatologists to rapidly and objectively support the diagnostic determination of whether a suspicious skin lesion is cancerous, thereby reducing the number of false negatives and eliminating unneeded escalation of care and biopsies. Veriskin's diagnostic method relies on (1) a single measurement to assess multiple parameters that characterize skin blood flow response to external mechanical force and (2) use of machine learning to recognize blood-flow differences between benign and cancerous skin lesions. In order to evaluate if this method could lead to a better, more accurate and more rapid support diagnosis tool of skin cancer, the current development stage of the TruScore is to train the TruScore AI algorithm on non-/pigmented skin lesions. Therefore, the purpose of this study is to collect non-/pigmented skin lesion TruScore Measurements from subjects who are undergoing standard-of-care skin cancer screening.

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Ramon, California, United States, 94583
        • Completed
        • Golden State Dermatology
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Golden State Dermatology
        • Principal Investigator:
          • Michael Wang, MD
        • Contact:
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Completed
        • Skin Care Research, LLC
      • Dania Beach, Florida, United States, 33004
        • Completed
        • Skin Care Research, LLC
      • Hollywood, Florida, United States, 33021
        • Completed
        • Skin Care Research, LLC
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Completed
        • Meridian Clinical Research
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Completed
        • Meridian Clinical Research
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Rajan Kulkarni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years or older
  • Primary lesions (i.e., not metastases or recurrent lesions) that the clinicians choose to biopsy.
  • Lesion 4mm in diameter or greater
  • Subject with multiple skin lesions, all lesions to be excised would be identified as individual skin lesions for the study. A maximum of 3 skin lesions may be measured per subject. Note: a subject may only be enrolled once into the study.
  • The subject is willing and able to read, comprehend and sign the study specific informed consent form.

Exclusion Criteria:

  • Skin surface not measurable (e.g., lesion on a stalk).
  • Skin surface not accessible (e.g., inside ears, under nails).
  • Lesion located on nose, lips, ears or eyelids.
  • Lesion located on acral skin (e.g., sole or palms).
  • Lesion located on areas of scars, crusts, psoriasis, eczema, dermatitis or similar skin conditions (i.e., any skin condition that could influence the blood flow where the lesion is located).
  • Lesion on hair-covered areas (e.g., scalp, beards, moustaches, or whiskers).
  • Lesion located on genitalia.
  • Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized.
  • Lesion located on mucosal surfaces.
  • Skin is not intact (measurement area) (e.g., bleeding or with clinical noticeable ulceration).
  • Lesion with foreign matter (e.g., tattoo, splinter).
  • Lesion and/or reference located on acute sunburn.
  • Collision lesions.
  • Patients with porphyria or other light sensitivities, such as phototoxicity or photoallergic from antibiotics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
The TruScore device will placed on a suspected skin lesion and activated. It will be held over the skin lesion and measurement completed in approximately 2 minutes
Device: TruScore
The TruScore device is a handheld battery powered device. It has a probe holding 3 fiber optic cables, one that delivers blue light for skin capillary interrogation, and the other 2 fiber optic cables collect the scattered light and quantifies the intensity using a photodetector. The device measures blood flow dynamics by introduction of mechanical perturbation by the operator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Collect non-/pigmented skin lesion TruScore assessments
Time Frame: 1 Day [Day of Skin Cancer Screening]
To assess non-/pigmented skin lesions with the TruScore AI algorithm.
1 Day [Day of Skin Cancer Screening]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device Safety, number of adverse device effects
Time Frame: 1 Day [Day of Skin Cancer Screening]
Estimate the rate of safety, number of adverse device effects when the TruScore Measurement is performed on a subject
1 Day [Day of Skin Cancer Screening]
Diagnostic Accuracy Rates
Time Frame: 1 Day [Day of Skin Cancer Screening]
Access diagnostic accuracy rates
1 Day [Day of Skin Cancer Screening]
Wong-Baker FACES Pain Rating Scale to measure pain level
Time Frame: 1 Day [Day of Skin Cancer Screening]
Rate subject's pain level when the TruScore Measurement is performed, 0-10, 0 No hurt-10 hurst the worst
1 Day [Day of Skin Cancer Screening]
System Usability Scale (SUS)
Time Frame: 1 Day [End of Study]
Evaluate end-users' perceived ease of use, 10 Questions, scale 1Strongly disagree-5 Stronlgy agree
1 Day [End of Study]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
[Redacted]

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Golden State Dermatology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Wang, MD, Golden State Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2021

Primary Completion

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-014

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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