Healthy VolunteersNCT05313555
The Effect of Violet Device Dosed Ultra Violet-C Light (UV-C) Exposure on Healthy Hand Skin
A study testing Ultraviolet Light (UV-B), Ultraviolet lights (UV-C) - 1 cycle and Ultraviolet lights (UV-C) - 10 cycles in people with Healthy Volunteers, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Ultraviolet Light (UV-B), Ultraviolet lights (UV-C) - 1 cycle and Ultraviolet lights (UV-C) - 10 cycles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to 12 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Violet Device Dosed UV-C Exposure on Healthy Hand Skin
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
- Being tested
- Ultraviolet Light (UV-B), Ultraviolet lights (UV-C) - 1 cycle, Ultraviolet lights (UV-C) - 10 cycles, Ultraviolet lights (UV-C) - 15 cycles, Ultraviolet lights (UV-C) - 25 cycles
- Keywords
- ultraviolet light, light skin, skin changes, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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) - 1 cycleDevice
Also called Violet UV-C Light, Care222
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.
Ultraviolet lights (UV-C) - 10 cyclesDevice
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) - 15 cyclesDevice
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) - 25 cyclesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultraviolet lights (UV-B) | Active comparator | Not described Receives: Device: Ultraviolet Light (UV-B) |
| Ultraviolet lights (UV-C) - 1 use | Experimental | Not described Receives: Device: Ultraviolet lights (UV-C) - 1 cycle |
| Ultraviolet lights (UV-C) - 10 uses | Experimental | Not described Receives: Device: Ultraviolet lights (UV-C) - 10 cycles |
| Ultraviolet lights (UV-C) - 15 uses | Experimental | Not described Receives: Device: Ultraviolet lights (UV-C) - 15 cycles |
| Ultraviolet lights (UV-C) - 25 uses | Experimental | Not described Receives: Device: Ultraviolet lights (UV-C) - 25 cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deoxyribonucleic Acid (DNA) Damage in the Form of DNA Base Pair Dimers Measured by Immunohistochemistry Microscopy With Statistical Analysis.
Measured: Day 1 (visit 1 after light therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start19 Apr 2022
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Why it stopped: The sponsoring company closed unexpectedly and was unable to continue to support the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Archimedes Innovations, Pbc
- Responsible party
- Principal investigator, Gary Fisher, University of Michigan
- Investigators
- Gary Fisher, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313555
- Sponsor's protocol ID
- HUM00198624
- Status last verified
- Jul 2025
- First submitted
- 28 Mar 2022
- Last updated
- 28 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Violet Device Dosed UV-C Exposure on Healthy Hand Skin
- ClinicalTrials.gov ID
- NCT05313555
- Acronym / sponsor ID
- HUM00198624
- Conditions
- Healthy Volunteers
- Keywords
- ultraviolet light, light skin, skin changes, healthy volunteers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsoring company closed unexpectedly and was unable to continue to support the study.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Archimedes Innovations, Pbc
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Posted 28 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultraviolet Light (UV-B)This control group will receive a UV-B exposure as a positive control. Participants will have punch biopsies after exposure. | Device | Ultraviolet lights (UV-B) |
| Ultraviolet lights (UV-C) - 1 cycleAlso: Violet UV-C Light, Care222Violet 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. | Device | Ultraviolet lights (UV-C) - 1 use |
| Ultraviolet lights (UV-C) - 10 cyclesViolet 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. | Device | Ultraviolet lights (UV-C) - 10 uses |
| Ultraviolet lights (UV-C) - 15 cyclesViolet 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. | Device | Ultraviolet lights (UV-C) - 15 uses |
| Ultraviolet lights (UV-C) - 25 cyclesViolet 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. | Device | Ultraviolet lights (UV-C) - 25 uses |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Fisher, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultraviolet Light (UV-B), Ultraviolet lights (UV-C) - 1 cycle and Ultraviolet lights (UV-C) - 10 cycles in people with Healthy Volunteers, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.