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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00494975
First received: June 29, 2007
Last updated: January 26, 2011
Last verified: September 2010

June 29, 2007
January 26, 2011
June 2007
July 2009   (final data collection date for primary outcome measure)
Visual Analogue Scale (VAS) Score for Pruritus [ Time Frame: VAS score at baseline and after 6 -week phototherapy ] [ Designated as safety issue: No ]

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

Visual Analogue Scale for pruritus [ Time Frame: 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 ]
Complete list of historical versions of study NCT00494975 on ClinicalTrials.gov Archive Site
Detailed Questionnaire at Baseline and After 18 Sessions [ Time Frame: at baseline and after 18 sessions ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease
The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Uremic Pruritus
Device: 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).
  • Experimental: NB-UVB
    Narrow band-Ultraviolet B phototherapy
    Intervention: Device: Narrow band UVB phototherapy , long wave UVA phototherapy
  • Placebo Comparator: UVA
    Ultraviolet A Phototherapy
    Intervention: Device: Narrow band UVB phototherapy , long wave UVA phototherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00494975
200704019R
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Mei-Ju Ko, MD Nationa l Taiwan University Hospital Yun-Lin branch
National Taiwan University Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP