Empirical clinical study of the homephototherapy

Not Applicable

• Conditions: Disease to become the adaptation of the dermatology phototherapy.

• Registration Number: JPRN-jRCTs042190092
• Lead Sponsor: Morita Akimichi

Brief Summary

Improvement was seen in psoriasis, atopic dermatitis, and vitiligo vulgaris. In the questionnaire about the degree of satisfaction of the study subjects regarding the effect, 66% of the subjects answered that they were satisfied. Compared with before and after using the this device at home, the study subjects' anxiety had been reduced. From the above, it was suggested that sufficient safety and efficacy could be secured in the home therapy of this device.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-09
• Study Completion: 2020-05-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1) Subjects with the treatment with dermatology phototherapy experience.
2) Subjects who have the part that I can irradiate by oneself.
3) Subjects are 20-79 years old at consent day.
4) Subjects with written consent about this study entry.

Exclusion Criteria

1) Subjects with the contraindications by the study device;
- Subjects with medical history/complication of the skin malignant tumor.
- Subjects of the high carcinogenic risk such as there being xeroderma pigmentosum, a radiation history of treatment, internal use and a contact career of arsenic.
- The subject who has a malignant tumor now.
- The subject who has severe photosensitivity.
2) Subjects considered that the self-irradiation of the medical device for this study is clearly difficult.
3) Subjects who participated in other clinical studies in the past 3 months.
4) Pregnant or possibly pregnant women, breastfeeding women, or women who wish to become pregnant during study participation.
5) In addition, the subjects that it is judged that participation in this study is inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Competence global evaluation as the at-home phototherapeutic device of this study device.

Secondary Outcome Measures

Name	Time	Method
1) Effectiveness<br>2) The use situation of the study device<br>3) Patient questionnaire