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

NCT ID: NCT00494975

Last Updated: 2011-01-27

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-07-31

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.

Conditions

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Uremic Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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NB-UVB

Narrow band-Ultraviolet B phototherapy

Group Type EXPERIMENTAL

Narrow band UVB phototherapy , long wave UVA phototherapy

Intervention Type DEVICE

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).

UVA

Ultraviolet A Phototherapy

Group Type PLACEBO_COMPARATOR

Narrow band UVB phototherapy , long wave UVA phototherapy

Intervention Type DEVICE

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).

Interventions

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Narrow band UVB phototherapy , long wave UVA phototherapy

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).

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

Principal Investigators

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Mei-Ju Ko, MD

Role: PRINCIPAL_INVESTIGATOR

Nationa l Taiwan University Hospital Yun-Lin branch

Locations

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Department of dermatology, National Taiwan Univeristy Hospital Yun-Lin branch

Douliu, Yunlin County, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 33283264 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21668425 (View on PubMed)

Other Identifiers

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200704019R

Identifier Type: -

Identifier Source: org_study_id

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