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

NCT ID: NCT05235334

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2023-04-12

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Device user

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

Group Type: EXPERIMENTAL

MySOLIUS

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BeneSol, Inc. dba SOLIUS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jashin J Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Office of Jashin Wu, M.D.

Chih-ho Hong, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Chih-ho Hong Medical Inc.

Locations

Office of Jashin J. Wu, MD

Irvine, California, United States

Dr. Chih-ho Hong Medical Inc.

Surrey, British Colimbia, Canada

Countries

United States; Canada

Other Identifiers

QR-TPL-042

Identifier Type: -

Identifier Source: org_study_id