Empirical clinical study of the homephototherapy

JRCT ID: jRCTs042190092

Registered date:09/12/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Disease to become the adaptation of the dermatology phototherapy.
• Date of first enrollment: 20/12/2019
• Target sample size: 12
• Study type: Interventional

Intervention(s)

1) Dermatology phototherapy with the ultraviolet rays treatment device in being at home.
2) Daily patient-diary description
3) Questionnaire answer before and after the phototherapy

Outcome(s)

• Primary Outcome: Competence global evaluation as the at-home phototherapeutic device of this study device.

Secondary Outcome

1) Effectiveness
2) The use situation of the study device
3) Patient questionnaire

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Morita Akimichi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development