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

Completed · Not applicable

Conditions studied: Usability, Quality of Life

In brief

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.

Key facts

Study ID

NCT05235334

Run by

BeneSol, Inc. dba SOLIUS

People needed

13

Starts

2021-10-12

Expected to finish

2023-04-12

Last updated by the study team

2023-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Office of Jashin J. Wu, MD — Irvine, California, United States
• Dr. Chih-ho Hong Medical Inc. — Surrey, British Colimbia, Canada

Full record on ClinicalTrials.gov

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