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The sponsoring company closed unexpectedly and was unable to continue to support the study.
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| Name | Class |
|---|---|
| Archimedes Innovations, Pbc | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultraviolet lights (UV-B) | Active Comparator |
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| Ultraviolet lights (UV-C) - 1 use | Experimental |
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| Ultraviolet lights (UV-C) - 10 uses | Experimental |
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| Ultraviolet lights (UV-C) - 15 uses | Experimental |
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| Ultraviolet lights (UV-C) - 25 uses | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | 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) |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Fisher, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Ultraviolet Lights (UV-C) - 1 Use |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2022 |
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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.
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| 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. |
|
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| 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) - 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) - 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) - 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.
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Deoxyribonucleic Acid (DNA) Damage in the Form of DNA Base Pair Dimers Measured by Immunohistochemistry Microscopy With Statistical Analysis. | 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. | Posted | Day 1 (visit 1 after light therapy) |
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Up to one week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suboptimal healing of biopsy site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Fisher, PhD | University of Michigan | 7347631469 | gjfisher@med.umich.edu |
| Feb 26, 2026 |
| Prot_SAP_000.pdf |
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