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

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: Withheld
• Conditions: Skin Cancer; Skin Lesion; Skin Melanoma; Skin Cancer, Non-Melanoma; Skin Cancers - Squamous Cell Carcinoma; Skin Cancers - Basal Cell Carcinoma
• Intervention / Treatment: Device: TruScore

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: Not Applicable

Contacts and Locations

• Study Contact: Name: Autumn Lang, PhD; Phone Number: 8587908187; Email: autumn@veriskin.com

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: Study Coordinator, PhD; Phone Number: 925-858-5370; Email: michal.weingart@gmail.com
  • 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: Clinical Trials Administrator; Email: schlichd@ohsu.edu
      • Principal Investigator: Rajan Kulkarni, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Collect non-/pigmented skin lesion TruScore assessments	To assess non-/pigmented skin lesions with the TruScore AI algorithm.	1 Day [Day of Skin Cancer Screening]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Safety, number of adverse device effects	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	Access diagnostic accuracy rates	1 Day [Day of Skin Cancer Screening]
Wong-Baker FACES Pain Rating Scale to measure pain level	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)	Evaluate end-users' perceived ease of use, 10 Questions, scale 1Strongly disagree-5 Stronlgy agree	1 Day [End of Study]

Collaborators and Investigators

• Sponsor: [Redacted]
• Collaborators: Golden State Dermatology
• Investigators: Principal Investigator: Michael Wang, MD, Golden State Dermatology

Study record dates

Study Major Dates

• Study Start: August 29, 2021
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Software as Medical Device; Skin Cancer Screening
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Skin Neoplasms; Carcinoma, Basal Cell
• Other Study ID 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