UsabilityNCT05235334
Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs
A study testing MySOLIUS in people with Usability and Quality of Life, run by Solius Labs, Inc. at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Usability, Quality of Life
- What is being tested?
- MySOLIUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Oct 2021to 12 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women, age 18 years or older with Fitzpatrick skin types 1,2,3,4,5 and 6.
- The patient can understand the information provided to them and who have given written informed consent to the study.
- The patient can understand and complete self-administered questionnaires.
- The patient is able and willing to follow study procedures.
- Women of child-bearing potential must confirm use of an effective contraceptive for 30 days prior to enrolling and continued use throughout the study or have a negative pregnancy test.
Who cannot join
- History of underlying photosensitivity.
- Subjects who are pregnant
- Patients that have granulomatous disorders (such as sarcoidosis).
- Use of medications that cause a photosensitivity reaction.
- History of skin cancer in the last 5 years.
- Patients with history of hypocalcemia (calcium <8.6mg%), hypercalcemia(calcium >10.6mg%).
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- Taking drugs known to influence vitamin D metabolism, such as glucocorticoids,antiseizure medications, or HIV/AIDS medications.
- Patients with a history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease within 3 months.
- Intentional artificial UV exposure (e.g. tanning bed, UVB phototherapy use) in the last 60 days or planned use while participating in the study.
- Participation in an investigational drug study within 30 days of the screening.
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Office of Jashin J. Wu, MD
Irvine, California, 92620
About this study
Official title: Light House- Pilot Study Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs
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.
Read the detailed description
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.
- Conditions
- Usability, Quality of Life
- Being tested
- MySOLIUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MySOLIUSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Device user | Experimental | Participant will engage in treatment with the MySOLIUS device, twice per week for 16 weeks Receives: Device: MySOLIUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: After study completion, 16 weeks
Secondary outcomes (2)
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.
Measured: Prior to starting treatment and after study completion, 16 weeks
Composite of adverse events and any skin changes
Participants will be asked weekly if they experience any adverse events or skin changes.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start12 Oct 2021
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UsabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will use the SOLIUS home device.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solius Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jashin J Wu, MD, Principal investigator, Office of Jashin Wu, M.D.Chih-ho Hong, MD, Principal investigator, Dr. Chih-ho Hong Medical Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235334
- Sponsor's protocol ID
- QR-TPL-042
- Status last verified
- Feb 2023
- First submitted
- 17 Jan 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light House- Pilot Study Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs
- ClinicalTrials.gov ID
- NCT05235334
- Acronym / sponsor ID
- QR-TPL-042
- Conditions
- Usability, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Solius Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will use the SOLIUS home device.
| Arm | Type | Receives |
|---|---|---|
| Device user | Experimental | Device: MySOLIUSParticipant will engage in treatment with the MySOLIUS device, twice per week for 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, age 18 years or older with Fitzpatrick skin types 1,2,3,4,5 and 6.
- The patient can understand the information provided to them and who have given written informed consent to the study.
- The patient can understand and complete self-administered questionnaires.
- The patient is able and willing to follow study procedures.
- Women of child-bearing potential must confirm use of an effective contraceptive for 30 days prior to enrolling and continued use throughout the study or have a negative pregnancy test.
Key exclusion criteria (11 listed)
- History of underlying photosensitivity.
- Subjects who are pregnant
- Patients that have granulomatous disorders (such as sarcoidosis).
- Use of medications that cause a photosensitivity reaction.
- History of skin cancer in the last 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MySOLIUSMySOLIUS 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. | Device | Device user |
Primary outcome
Satisfaction of Users with the device by a non-professional in a home use environment.
Time frame: After study completion, 16 weeks
Participants will be surveyed on their satisfaction with the MySOLIUS device on a scale of Strongly Disagree (1) to Strongly Agree (7)
2 secondary outcomes
Increase in the quality of life scale.
Time frame: Prior to starting treatment and after study completion, 16 weeks
Composite of adverse events and any skin changes
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jashin J Wu, MD principal investigator
Office of Jashin Wu, M.D.
Chih-ho Hong, MD principal investigator
Dr. Chih-ho Hong Medical Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MySOLIUS in people with Usability and Quality of Life, run by Solius Labs, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of Users with the device by a non-professional in a home use environment. (time frame: After study completion, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.