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Jan. 29, 2019

Jan. 28, 2023

jRCTs052180032

Narrowband ultraviolet B phototherapy for the treatment of pruritus induced by chronic liver disease and cholestasis (Narrowband ultraviolet B phototherapy for the treatment of pruritus induced by chronic liver disease and cholestasis)

Narrowband ultraviolet B phototherapy for the treatment of pruritus induced by chronic liver disease and cholestasis (Narrowband ultraviolet B phototherapy for the treatment of pruritus induced by chronic liver disease and cholestasis)

Dec. 31, 2022

2

The study was conducted on the following two subjects. (1) Female (age at consent to participate in the study: 42 years, date of consent: 2019/03/04) (2) Male (age at consent to participate in the study: 84 years, date of consent: 2019/09/01)

Only the above two individuals were included in the study.

Both subjects (1) and (2) had no occurrence of disease attributable to this clinical study.

Since only the above two subjects were included in the study, no statistical analysis was performed. The changes in the degree of pruritic skin symptoms (VAS score and itch score) for each subject were as follows. Subject (1) showed some improvement of symptoms during irradiation, but long-term control was not achieved, and relapse of symptoms was observed after the end of irradiation. In subject (2), itchy skin symptoms improved early after the start of narrowband UVB therapy, and the improvement was relatively maintained after the end of irradiation.

Although statistical analysis was difficult because only two subjects were studied, one showed improvement of pruritic symptoms with narrowband UVB therapy, but one did not show long-term control and had flare-ups of symptoms after the end of irradiation.

Jan. 28, 2023

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs052180032

Takai Atsushi

Kyoto University Hospital

54 Kawahara-cho, Syogoin, Sakyo-ku, Kyoto

+81-75-751-4319

atsushit@kuhp.kyoto-u.ac.jp

Eso Yuji

Kyoto University Hospital

54 Kawahara-cho, Syogoin, Sakyo-ku, Kyoto

+81-75-751-4319

yujieso@kuhp.kyoto-u.ac.jp

Complete

Jan. 01, 2019

30

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients eligible for preregistration were those: (i) with
chronic liver disease or cholestasis including chronic hepatitis, cirrhosis, PSC, and PBC; (ii) who were at least 20 years of age at the time of
informed consent; (iii) mean VAS>50 mm in one week, or VAS of >20 mm on 5 or more days per week, or pruritus scores >3 on 4 or more days per week.

Patients with psychiatric disorder, dementia, dermatosis, or chronic renal disease.

20age old over
No limit

Both

chronic liver disease or cholestasis including chronic hepatitis, cirrhosis, PSC, and PBC

Narrowband UVB phototherapy is performed once a week, starting at 0.3 to 0.5 J / cm2 and increasing by 0.05 to 0.1 J / cm2 (up to 1.5 J / cm2) depending on the therapeutic effect. The total number of phototherapy should be 24 at the maximum, and if sufficient effect is obtained and patient's consent is obtained, phototherapy can be terminated at the judgment of the attending physician.

chronic liver disease

Narrowband ultraviolet B phototherapy

D006521

D010789

Utility of narrowband ultraviolet B phototherapy for patients with
refractory hepatic pruritus

None

MSD
Not applicable
Kyoto University Certified Review Board
Yoshida-konoe cho, Sakyo-ku, Kyoto, Kyoto

+81-75-753-4680

ethcom@kuhp.kyoto-u.ac.jp
Approval

Dec. 10, 2018

該当なし
None

none

History of Changes

No Publication date
4 Jan. 28, 2023 (this page) Changes
3 Mar. 11, 2020 Detail Changes
2 Jan. 17, 2020 Detail Changes
1 Jan. 29, 2019 Detail