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
| 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
| 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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place