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The primary objective of this study is to evaluate the satisfaction of users with the MySOLIUS device by a non-professional in a home use environment. The secondary objective of this study is to demonstrate the safety and effectiveness of the MySOLIUS device in the improvement of mood/quality of life score.
After being informed about the study and potential risks, all patients giving written informed consent will be screened to determine eligibility for study entry. Participants who meet the eligibility requirements will be sent a study device to use in their home environment. Prior to beginning treatment with the device, participants will fill out a quality of life questionnaire. Participants will use the device twice per week, once for treatment on the front side and once for treatment on the back side of the body. Participants will use the device twice a week for 16 weeks, for a total of 32 treatments. After the 16 week treatment duration, participants will fill out a final quality of life questionnaire and a device usability questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device user | Experimental | Participant will engage in treatment with the MySOLIUS device, twice per week for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MySOLIUS | Device | MySOLIUS is a portable light therapy device that is designed to deliver a small amount of targeted ultraviolet B (UVB) light to trigger the body's natural production of vitamin D. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of Users with the device by a non-professional in a home use environment. | Participants will be surveyed on their satisfaction with the MySOLIUS device on a scale of Strongly Disagree (1) to Strongly Agree (7) | After study completion, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in the quality of life scale. | Participants will be surveyed on a variety of quality of life questions. Scores range from a minimum value of 0 to a maximum value of 1,300 with higher scores indicating a better quality of life. | Prior to starting treatment and after study completion, 16 weeks |
| Composite of adverse events and any skin changes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jashin J Wu, MD | Office of Jashin Wu, M.D. | Principal Investigator |
| Chih-ho Hong, MD | Dr. Chih-ho Hong Medical Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Office of Jashin J. Wu, MD | Irvine | California | 92620 | United States | ||
| Dr. Chih-ho Hong Medical Inc. |
Individual participant data will not be made available to other researchers.
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All enrolled participants will use the SOLIUS home device.
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No masking will be used
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Participants will be asked weekly if they experience any adverse events or skin changes. |
| 16 weeks |
| Surrey |
| British Colimbia |
| V3R 6A7 |
| Canada |