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NCT Number: NCT07188948

In Vivo Cross-Modal Imaging of Skin

The overall objective of this study is to use VIO/FG-30350 ("VIO") to observe microscopic skin structure in people of different skin health at different anatomic locations and correlate microscopic features with macroscopic features.

Recruiting

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Key information

Conditions

Age range

2 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Enspectra Health

Mountain View, California, 94040, United States

Location status: Recruiting

Location contact

Bill Beasley

CONTACT

[email protected]

Esha J Kothari

CONTACT

[email protected]

(650) 480-6022

Gabriel Sanchez, PhD

PRINCIPAL_INVESTIGATOR

About this study

The overall objective of this study is to use VIO/FG-30350 ("VIO") to observe microscopic skin structure in people of different skin health at different anatomic locations and correlate microscopic features with macroscopic features.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants, ages 2 - 90 years old

Participant, or guardian, if applicable, must be willing to provide written informed consent prior to enrollment and agree to comply with protocol requirements. If applicable, child must be willing to provide written assent prior to enrollment and agree to comply with protocol requirements.

Participant or guardian, if applicable, must have sufficient mental capacity to understand the Informed Consent and provide clinically relevant and reliable feedback regarding their experience with the device.

Participant and guardian, if applicable, must comply with the protocol requirements.

Participant or guardian, if applicable, must agree that anonymized personal data will be made available to Study Sponsor and requisite regional and international regulatory bodies

Exclusion criteria

Any general health condition or systemic disease that may represent, in the opinion of the Principal Investigator, a potential increased risk associated with device use

Currently infected with a communicable skin infection (e.g., shingles or methicillin-resistant S. aureus), which does not include local and minimally pathogenic or non-pathogenic infections distant from the imaging location(s) (e.g., warts, acne)

Any known allergies to any materials used in the preparation of skin and/or device use

Has a temporary or permanent electrical implanted medical device

-

Treatment and study plan

Skin conditions

Device

Participants with skin conditions such as AK or participants without any skin conditions (healthy skin)

Skin Condition

Device

Participants with Skin conditions or participants without any skin conditions (Healthy)

Primary outcomes

  1. Correlational relationship

    Time frame: 7 days

    Correlational relationship of:

    melanin content quantified from noninvasive VIO images with

    macroscopic skin tone as measured with a colorimeter.

  2. Correlational relationship

    Time frame: 7 days

    Correlational relationship of:

    • melanin content quantified from noninvasive VIO images with
    • macroscopic skin tone as measured with a colorimeter.

Sponsors and collaborators

Lead sponsor

Gabriel Sanchez

Industry

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

In Vivo Cross-Modal Imaging of Skin - VISION2

Acronym: VISION2

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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