The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease
Primary Purpose
Uremic Pruritus
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Narrow band UVB phototherapy , long wave UVA phototherapy
Sponsored by
About this trial
This is an interventional treatment trial for Uremic Pruritus
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
Sites / Locations
- Department of dermatology, National Taiwan Univeristy Hospital Yun-Lin branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NB-UVB
UVA
Arm Description
Narrow band-Ultraviolet B phototherapy
Ultraviolet A Phototherapy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Detailed Questionnaire at Baseline and After 18 Sessions
Full Information
NCT ID
NCT00494975
First Posted
June 29, 2007
Last Updated
January 26, 2011
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00494975
Brief Title
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
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NB-UVB
Arm Type
Experimental
Arm Description
Narrow band-Ultraviolet B phototherapy
Arm Title
UVA
Arm Type
Placebo Comparator
Arm Description
Ultraviolet A Phototherapy
Intervention Type
Device
Intervention Name(s)
Narrow band UVB phototherapy , long wave UVA phototherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) Score for Pruritus
Description
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
Time Frame
VAS score at baseline and after 6 -week phototherapy
Secondary Outcome Measure Information:
Title
Detailed Questionnaire at Baseline and After 18 Sessions
Time Frame
at baseline and after 18 sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Ju Ko, MD
Organizational Affiliation
Nationa l Taiwan University Hospital Yun-Lin branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of dermatology, National Taiwan Univeristy Hospital Yun-Lin branch
City
Douliou City
State/Province
Yunlin County
ZIP/Postal Code
640
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
33283264
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.
Results Reference
derived
PubMed Identifier
21668425
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.
Results Reference
derived
Learn more about this trial
The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease
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