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

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05313555
Collaborator
Archimedes Innovations, Pbc (Other)
30
Enrollment
1
Location
2
Arms
11.4
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultraviolet Light (UV-B)
  • Device: Ultraviolet lights (UV-C)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Violet Device Dosed UV-C Exposure on Healthy Hand Skin
Actual Study Start Date :
Apr 19, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ultraviolet lights (UV-B)

Device: Ultraviolet Light (UV-B)
This control group will receive a UV-B exposure as a positive control. Participants will have punch biopsies after exposure.
Experimental: Ultraviolet lights (UV-C)

Device: Ultraviolet lights (UV-C)
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.
Other Names:
  • Violet UV-C Light
  • Care222

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan
    • Archimedes Innovations, Pbc

    Investigators

    • Principal Investigator: Gary Fisher, PhD, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gary Fisher, Professor, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT05313555
    Other Study ID Numbers:
    • HUM00198624
    First Posted:
    Apr 6, 2022
    Last Update Posted:
    May 16, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Gary Fisher, Professor, University of Michigan
    ultraviolet light
    light skin
    skin changes
    healthy volunteers

    Study Results

    No Results Posted as of May 16, 2022