Skin
Conditions
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.
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.
Interventions
DEVICESkin conditions
Participants with skin conditions such as AK or participants without any skin conditions (healthy skin)
DEVICESkin Condition
Participants with Skin conditions or participants without any skin conditions (Healthy)
Sponsors
National Cancer Institute (NCI)
Gabriel Sanchez
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 90 Years
Healthy volunteers
Yes
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlational relationship | 7 days | Correlational relationship of: melanin content quantified from noninvasive VIO images with macroscopic skin tone as measured with a colorimeter. |
Countries
United States
Outcome results
None listed