Clinical trial NCT05235334: Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs
Official title: Light House- Pilot Study Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Usability
Quality of Life
Lead sponsor: BeneSol, Inc. dba SOLIUS
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All enrolled participants will use the SOLIUS home device.
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: Satisfaction of Users with the device by a non-professional in a home use environment.
timeFrame: After study completion, 16 weeks
Secondary outcomes:
measure: Increase in the quality of life scale.
timeFrame: Prior to starting treatment and after study completion, 16 weeks
measure: Composite of adverse events and any skin changes
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Office of Jashin J. Wu, MD
state: California
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Colimbia
Study officials:
affiliation: Office of Jashin Wu, M.D.
name: Jashin J Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Chih-ho Hong Medical Inc.
name: Chih-ho Hong, MD
role: PRINCIPAL_INVESTIGATOR
References: