Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs

Quality of Life Clinical Trial

Official title:

Light House- Pilot Study Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235334
• Other study ID #: QR-TPL-042
• Status: Completed
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: April 12, 2023

Study information

• Verified date: February 2023
• Source: BeneSol, Inc. dba SOLIUS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life
• Usability

Intervention

Device:
• MySOLIUS
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.

Locations

Country	Name	City	State
Canada	Dr. Chih-ho Hong Medical Inc.	Surrey	British Colimbia
United States	Office of Jashin J. Wu, MD	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
BeneSol, Inc. dba SOLIUS

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Composite of adverse events and any skin changes	Participants will be asked weekly if they experience any adverse events or skin changes.	16 weeks