Trial Outcomes & Findings for The Effect of Violet Device Dosed Ultra Violet-C Light (UV-C) Exposure on Healthy Hand Skin (NCT NCT05313555)

NCT ID: NCT05313555

Last Updated: 2026-05-28

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

Day 1 (visit 1 after light therapy)

Results posted on

2026-05-28

Participant Flow

Participant milestones

Participant milestones
Measure
Ultraviolet Lights (UV-B)
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) - 1 Use
Ultraviolet lights (UV-C) - 1 cycle: 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 Uses
Ultraviolet lights (UV-C) - 10 cycles: 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 Uses
Ultraviolet lights (UV-C) - 15 cycles: 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 Uses
Ultraviolet lights (UV-C) - 25 cycles: 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.
Overall Study
STARTED
3
6
4
6
4
Overall Study
COMPLETED
3
6
4
6
4
Overall Study
NOT COMPLETED
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ultraviolet Lights (UV-B)
n=3 Participants
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) - 1 Use
n=6 Participants
Ultraviolet lights (UV-C) - 1 cycle: 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 Uses
n=4 Participants
Ultraviolet lights (UV-C) - 10 cycles: 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 Uses
n=6 Participants
Ultraviolet lights (UV-C) - 15 cycles: 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 Uses
n=4 Participants
Ultraviolet lights (UV-C) - 25 cycles: 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.
Total
n=23 Participants
Total of all reporting groups
Age, Continuous
20.33 years
n=3 Participants
28.83 years
n=6 Participants
23.5 years
n=4 Participants
36.17 years
n=6 Participants
26.5 years
n=4 Participants
27.74 years
n=23 Participants
Sex: Female, Male
Female
3 Participants
n=3 Participants
5 Participants
n=6 Participants
3 Participants
n=4 Participants
6 Participants
n=6 Participants
4 Participants
n=4 Participants
21 Participants
n=23 Participants
Sex: Female, Male
Male
0 Participants
n=3 Participants
1 Participants
n=6 Participants
1 Participants
n=4 Participants
0 Participants
n=6 Participants
0 Participants
n=4 Participants
2 Participants
n=23 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
3 Participants
n=3 Participants
6 Participants
n=6 Participants
4 Participants
n=4 Participants
6 Participants
n=6 Participants
4 Participants
n=4 Participants
23 Participants
n=23 Participants

PRIMARY outcome

Timeframe: Day 1 (visit 1 after light therapy)

Population: The sponsoring company closed unexpectedly after biopsy samples were obtained from participants, but before the samples could be analyzed. Sample analysis could not take place due to lack of funding from the sponsor and will not be done in the future. Consequently, there is no data to report, as the physical samples generated no data.

Outcome measures

Outcome data not reported

Adverse Events

Ultraviolet Lights (UV-B)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ultraviolet Lights (UV-C) - 1 Use

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Ultraviolet Lights (UV-C) - 10 Uses

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ultraviolet Lights (UV-C) - 15 Uses

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ultraviolet Lights (UV-C) - 25 Uses

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Ultraviolet Lights (UV-B)
n=3 participants at risk
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) - 1 Use
n=6 participants at risk
Ultraviolet lights (UV-C) - 1 cycle: 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 Uses
n=4 participants at risk
Ultraviolet lights (UV-C) - 10 cycles: 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 Uses
n=6 participants at risk
Ultraviolet lights (UV-C) - 15 cycles: 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 Uses
n=4 participants at risk
Ultraviolet lights (UV-C) - 25 cycles: 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.
Skin and subcutaneous tissue disorders
Suboptimal healing of biopsy site
0.00%
0/3 • Up to one week
16.7%
1/6 • Up to one week
0.00%
0/4 • Up to one week
0.00%
0/6 • Up to one week
0.00%
0/4 • Up to one week

Additional Information

Gary Fisher, PhD

University of Michigan

Phone: 7347631469

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place