Clinical trial NCT00494975: The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease
Official title: The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uremic Pruritus
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2007-07-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to confirm the efficacy of NB UVB phototherapy in alleviating uremic pruritus and investigate the association between improvement of pruritus and change of serum parameters, including routine biochemical data, immune profile and dialysis adequacy.

Detailed description: We would conduct a randomized study to evaluate the effect of NB UVB therapy on uremic pruritus. The intensity of pruritus will be evaluated using visual analog scale (VAS) score (0 \[no pruritus\]-10 most severe pruritus\]) and a detailed questionnaire assessing various characteristics of pruritus at baseline . The patients with the intensity of pruritus VAS score more than 5 will be randomized to narrow band UVB and control group. Phototherapy was administered to the whole body surface 2-3 sessions per week for total 18 sessions in a UV irradiation cubicle. The dose increased from 210mJ/cm2 .Doses were increased by 10 % at every session. The control group received time-matched exposures to long-wave ultraviolet light. The investigator will determine the pruritic intensity at baseline every 3 sessions by VAS score and by detailed questionnaire at baseline and after 18 sessions. The blood sample will also be collected at baseline and after treatment to determine factors associated with improvement.

Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease with moderate to severe uremic pruritus for longer than 2 months

Exclusion Criteria:

* pregnancy history of photosensitivity photo-aggravated disease

Primary outcomes:
measure: Visual Analogue Scale (VAS) Score for Pruritus
timeFrame: VAS score at baseline and after 6 -week phototherapy
Secondary outcomes:
measure: Detailed Questionnaire at Baseline and After 18 Sessions
timeFrame: at baseline and after 18 sessions
Other outcomes:
Locations:
city: Douliou City
country: Taiwan
facility: Department of dermatology, National Taiwan Univeristy Hospital Yun-Lin branch
state: Yunlin County
Study officials:
affiliation: Nationa l Taiwan University Hospital Yun-Lin branch
name: Mei-Ju Ko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
citation: Ko MJ, Yang JY, Wu HY, Hu FC, Chen SI, Tsai PJ, Jee SH, Chiu HC. Narrowband ultraviolet B phototherapy for patients with refractory uraemic pruritus: a randomized controlled trial. Br J Dermatol. 2011 Sep;165(3):633-9. doi: 10.1111/j.1365-2133.2011.10448.x.