- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05235334
Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs
April 24, 2023 updated by: BeneSol, Inc. dba SOLIUS
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Colimbia
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Surrey, British Colimbia, Canada, V3R 6A7
- Dr. Chih-Ho Hong Medical Inc.
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California
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Irvine, California, United States, 92620
- Office of Jashin J. Wu, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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%).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Device user
Participant will engage in treatment with the MySOLIUS device, twice per week for 16 weeks
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction of Users with the device by a non-professional in a home use environment.
Time Frame: After study completion, 16 weeks
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Participants will be surveyed on their satisfaction with the MySOLIUS device on a scale of Strongly Disagree (1) to Strongly Agree (7)
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After study completion, 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase in the quality of life scale.
Time Frame: Prior to starting treatment and after study completion, 16 weeks
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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.
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Prior to starting treatment and after study completion, 16 weeks
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Composite of adverse events and any skin changes
Time Frame: 16 weeks
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Participants will be asked weekly if they experience any adverse events or skin changes.
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16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 12, 2021
Primary Completion (Actual)
April 12, 2023
Study Completion (Actual)
April 12, 2023
Study Registration Dates
First Submitted
January 17, 2022
First Submitted That Met QC Criteria
February 1, 2022
First Posted (Actual)
February 11, 2022
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 24, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- QR-TPL-042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be made available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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