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NCT05313555 Clinical Trial

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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05313555
Other study ID # HUM00198624
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 19, 2022
Est. completion date April 2025

Study information
Verified date March 2024
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (2)
Lead Sponsor Collaborator
University of Michigan Archimedes Innovations, Pbc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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)
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