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

BeneSol (SOLIUS)

Status

Completed

Conditions

Quality of Life

Usability

Treatments

Device: MySOLIUS

Study type

Interventional

Funder types

Industry

Identifiers

NCT05235334

QR-TPL-042

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.