Status:
COMPLETED
Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs
Lead Sponsor:
BeneSol, Inc. dba SOLIUS
Conditions:
Usability
Quality of Life
Eligibility:
All Genders
18+ years
Phase:
NA
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 demon...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05235334
Start Date
October 12 2021
End Date
April 12 2023
Last Update
April 25 2023
Active Locations (2)
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1
Office of Jashin J. Wu, MD
Irvine, California, United States, 92620
2
Dr. Chih-ho Hong Medical Inc.
Surrey, British Colimbia, Canada, V3R 6A7