The Effect of Violet Device Dosed Ultra Violet-C Light (UV-C) Exposure on Healthy Hand Skin

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the safety of ultraviolet light (UV-C) irradiation as a method to sanitize hands instead of chemical-based sanitizers. Eligible participants will be enrolled and receive treatment with the Violet UV-C device or UV-B. Punch biopsies will be performed following UV exposure to quantify any changes in cellular and molecular properties of the tissue.

Official Title
-----------------
The Effect of Violet Device Dosed UV-C Exposure on Healthy Hand Skin

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Device: Ultraviolet Light (UV-B)
* Device: Ultraviolet lights (UV-C)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Good general health Type 1 or type 2 skin (lightly colored skin) No history of skin disorders, disease states or physical conditions which would impair evaluation of the test sites Willingness and ability to follow the protocol No use of lotion or hand sanitizer 3 hours before the experiment Exclusion Criteria: Has received an experimental drug or used an experimental device in the 30 days prior to admission to the study Undergoing treatment or taking medication that increases sun sensitivity History of keloids History of sensitivity to lidocaine or epinephrine Pregnant or nursing women, pregnancy status will be self-reported, women unsure of their pregnancy status will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultraviolet lights (UV-B)<br> | Device: Ultraviolet Light (UV-B)<br>* This control group will receive a UV-B exposure as a positive control. Participants will have punch biopsies after exposure.<br>|
| Experimental: Ultraviolet lights (UV-C)<br> | Device: Ultraviolet lights (UV-C)<br>* Violet is tabletop device that emits filtered UV-C (200nm-230nm; peak at 222nm). Participants will choose, based on availability, to be in groups that deliver 1 cycle, 10 cycles, 15 cycles or 25 cycles of the Violet. The subject will be exposed for no more than 5 minutes and 20 seconds in total. Participants will have punch biopsies after exposure.<br>* Other names: Care222;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deoxyribonucleic acid (DNA) damage in the form of DNA base pair dimers measured by immunohistochemistry microscopy with statistical analysis. |  | Day 1 (visit 1 after light therapy) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultraviolet light, light skin, skin changes, healthy volunteers