Recruiting

VIO

Sponsor:

Gabriel Sanchez

Code:

NCT07188948

Conditions

Skin

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

Interventions

Skin conditions

Skin Condition

Study Details

Brief summary:

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.

Conditions

Skin

Study ID

NCT07188948

Start date

Sep 2, 2025

Status verified date

Sep, 2025

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

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

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Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Interventions

Skin conditions

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

Skin Condition

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

Primary outcome measure

  • Correlational relationship [ Time Frame: 7 days ]
  • Correlational relationship [ Time Frame: 7 days ]

Central Contacts and Locations

Locations

Enspectra Health

Recruiting

Mountain View, California, United States, 94040

Contacts

Principal Investigator:

Gabriel Sanchez, PhD

More Information

Sponsor

Gabriel Sanchez

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gabriel Sanchez on 2025-09-23.