Healthy Volunteers
Conditions
Keywords
ultraviolet light, light skin, skin changes, healthy volunteers
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.
Interventions
DEVICEUltraviolet Light (UV-B)
This control group will receive a UV-B exposure as a positive control. Participants will have punch biopsies after exposure.
DEVICEUltraviolet 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.
DEVICEUltraviolet 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.
DEVICEUltraviolet 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.
DEVICEUltraviolet 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.
Sponsors
University of Michigan
Archimedes Innovations, Pbc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGary Fisher, PhD
University of Michigan
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 27.74 years |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 6 | 0 / 4 | 0 / 6 | 0 / 4 |
| other Total, other adverse events | 0 / 3 | 1 / 6 | 0 / 4 | 0 / 6 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 6 | 0 / 4 | 0 / 6 | 0 / 4 |
Outcome results
None listed