SkinVISION2NCT07188948
In Vivo Cross-Modal Imaging of Skin
An observational study of Skin, run by Gabriel Sanchez at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin
- What is being tested?
- Skin conditions and Skin Condition
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Recruitment Clinics and Healthy Participants
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Enspectra Health
Mountain View, California, 94040
Esha J Kothari, (650) 480-6022, esha.kothari@enspectrahealth.com
Bill Beasley, info@enspectrahealth.com
About this study
Official title: In Vivo Cross-Modal Imaging of Skin - VISION2
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.
Read the detailed description
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
- Being tested
- Skin conditions, Skin Condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin conditionsDevice
Participants with skin conditions such as AK or participants without any skin conditions (healthy skin)
Skin ConditionDevice
Participants with Skin conditions or participants without any skin conditions (Healthy)
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlational relationship
Correlational relationship of:
melanin content quantified from noninvasive VIO images with
macroscopic skin tone as measured with a colorimeter.
Measured: 7 days
Correlational relationship
Correlational relationship of:
- melanin content quantified from noninvasive VIO images with
- macroscopic skin tone as measured with a colorimeter.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start2 Sep 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SkinStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gabriel Sanchez
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Gabriel Sanchez, Enspectra Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188948
- Sponsor's protocol ID
- CR-30359
- Other IDs
- 5R44CA285138-02
- Acronym
- VISION2
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Cross-Modal Imaging of Skin - VISION2
- ClinicalTrials.gov ID
- NCT07188948
- Acronym / sponsor ID
- VISION2 / CR-30359
- Conditions
- Skin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Gabriel SanchezIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Recruitment Clinics and Healthy Participants
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- -
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 |
|---|---|---|
| Skin conditionsParticipants with skin conditions such as AK or participants without any skin conditions (healthy skin) | Device | – |
| Skin ConditionParticipants with Skin conditions or participants without any skin conditions (Healthy) | Device | – |
Primary outcome
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.
Correlational relationship
Time frame: 7 days
Correlational relationship of: 1. melanin content quantified from noninvasive VIO images with 2. macroscopic skin tone as measured with a colorimeter.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin, run by Gabriel Sanchez 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlational relationship (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2025.