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

N/AActive Not RecruitingNCT05313555

University of Michigan30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Ultraviolet Light (UV-B)DEVICE

This control group will receive a UV-B exposure as a positive control. Participants will have punch biopsies after exposure.

Ultraviolet lights (UV-C)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Deoxyribonucleic acid (DNA) damage in the form of DNA base pair dimers measured by immunohistochemistry microscopy with statistical analysis.

Time frame: Day 1 (visit 1 after light therapy)

Data from ClinicalTrials.gov

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