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

NCT05313555 | Terminated Results FDA Device

• 1 other identifier: HUM00198624
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

ultraviolet light; light skin; skin changes; healthy volunteers

Outcome Measures

Primary Outcomes (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)

Study Arms (5)

Ultraviolet lights (UV-B)

ACTIVE COMPARATOR

Device: Ultraviolet Light (UV-B)

Ultraviolet lights (UV-C) - 1 use

EXPERIMENTAL

Device: Ultraviolet lights (UV-C) - 1 cycle

Ultraviolet lights (UV-C) - 10 uses

EXPERIMENTAL

Device: Ultraviolet lights (UV-C) - 10 cycles

Ultraviolet lights (UV-C) - 15 uses

EXPERIMENTAL

Device: Ultraviolet lights (UV-C) - 15 cycles

Ultraviolet lights (UV-C) - 25 uses

EXPERIMENTAL

Device: Ultraviolet lights (UV-C) - 25 cycles

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-B)

Ultraviolet lights (UV-C) - 1 cycle DEVICE

Violet is tabletop device that emits filtered UV-C (200nm-230nm; peak at 222nm). Participants will be exposed to 1 cycle 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.

Also known as: Violet UV-C Light, Care222

Ultraviolet lights (UV-C) - 1 use

Ultraviolet lights (UV-C) - 10 cycles DEVICE

Violet is tabletop device that emits filtered UV-C (200nm-230nm; peak at 222nm). Participants will be exposed to 10 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.

Ultraviolet lights (UV-C) - 10 uses

Ultraviolet lights (UV-C) - 15 cycles DEVICE

Violet is tabletop device that emits filtered UV-C (200nm-230nm; peak at 222nm). Participants will be exposed to 15 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.

Ultraviolet lights (UV-C) - 15 uses

Ultraviolet lights (UV-C) - 25 cycles DEVICE

Violet is tabletop device that emits filtered UV-C (200nm-230nm; peak at 222nm). Participants will be exposed to 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.

Ultraviolet lights (UV-C) - 25 uses

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Archimedes Innovations, Pbc: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Results Point of Contact

• Title: Gary Fisher, PhD
• Organization: University of Michigan

gjfisher@med.umich.edu

7347631469

Study Officials

• Gary Fisher, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants were randomized into UV-B and UV-C groups. Those who were randomized into the UV-C group were then able to choose how many cycles of UV-C exposure they would receive.

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 6, 2022
• Study Start: April 19, 2022
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: May 28, 2026
• Results First Posted: May 28, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)