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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
History of Changes
  Purpose

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.


Condition Intervention
Uremic Pruritus
 Device: Narrow band UVB phototherapy , long wave UVA phototherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • Detailed Questionnaire at Baseline and After 18 Sessions [ Time Frame: at baseline and after 18 sessions ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: June 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NB-UVB
Narrow band-Ultraviolet B phototherapy
 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).
Placebo Comparator: UVA
Ultraviolet A Phototherapy
 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).

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494975

Locations
Taiwan
Department of dermatology, National Taiwan Univeristy Hospital Yun-Lin branch
Douliou City, Yunlin County, Taiwan, 640
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Mei-Ju Ko, MD Nationa l Taiwan University Hospital Yun-Lin branch
  More Information

No publications provided by National Taiwan University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00494975     History of Changes
Other Study ID Numbers: 200704019R
Study First Received: June 29, 2007
Results First Received: October 5, 2010
Last Updated: January 26, 2011
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Kidney Diseases
Pruritus
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
 Skin Diseases
Skin Manifestations
Signs and Symptoms
Renal Insufficiency

ClinicalTrials.gov processed this record on May 22, 2013