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

NCT05235334 | Completed FDA Device

• 1 other identifier: QR-TPL-042
• Study Type: interventional
• Target: 13
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Usability; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Increase in the quality of life scale.

  Prior to starting treatment and after study completion, 16 weeks

• Composite of adverse events and any skin changes

  16 weeks

Study Arms (1)

Device user

EXPERIMENTAL

Participant will engage in treatment with the MySOLIUS device, twice per week for 16 weeks

Device: MySOLIUS

Interventions

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.

Device user

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeneSol, Inc. dba SOLIUS: lead

Study Sites (2)

Office of Jashin J. Wu, MD

Irvine, California, 92620, United States

Location

Dr. Chih-ho Hong Medical Inc.

Surrey, British Colimbia, V3R 6A7, Canada

Location

Study Officials

• Jashin J Wu, MD

  Office of Jashin Wu, M.D.

  PRINCIPAL INVESTIGATOR

• Chih-ho Hong, MD

  Dr. Chih-ho Hong Medical Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking will be used
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants will use the SOLIUS home device.

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 11, 2022
• Study Start: October 12, 2021
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)