The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease

Conditions
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Uremic Pruritus

Intervention / Treatment
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* Device: Narrow band UVB phototherapy , long wave UVA phototherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NB-UVB<br>Narrow band-Ultraviolet B phototherapy | Device: Narrow band UVB phototherapy , long wave UVA phototherapy<br>* A UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. ) and 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).<br>|
| Placebo Comparator: UVA<br>Ultraviolet A Phototherapy | Device: Narrow band UVB phototherapy , long wave UVA phototherapy<br>* A UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. ) and 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) Score for Pruritus | a VAS is a horizontal line, 100 mm in length. The patient marks on the line the point that they feel represents their perception of their pruritus. 0 (no pruritus) - 10 (most severe pruritus) 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 | VAS score at baseline and after 6 -week phototherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detailed Questionnaire at Baseline and After 18 Sessions |  | at baseline and after 18 sessions |