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
Results First Received: October 5, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Uremic Pruritus
Intervention: Device: Narrow band UVB phototherapy , long wave UVA phototherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ultraviolet A 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. )
Narrow Band Ultraviolet B Phototherapy a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).

Participant Flow:   Overall Study
    Ultraviolet A Phototherapy     Narrow Band Ultraviolet B Phototherapy  
STARTED     10     11  
COMPLETED     8     10  
NOT COMPLETED     2     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ultraviolet A 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. )
Narrow Band Ultraviolet B Phototherapy a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
Total Total of all reporting groups

Baseline Measures
    Ultraviolet A Phototherapy     Narrow Band Ultraviolet B Phototherapy     Total  
Number of Participants  
[units: participants]
  10     11     21  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     7     12  
>=65 years     5     4     9  
Age  
[units: years]
Mean ± Standard Deviation
  63.2  ± 11.3     60.9  ± 11.5     62.0  ± 11.2  
Gender  
[units: participants]
     
Female     5     5     10  
Male     5     6     11  
Region of Enrollment  
[units: participants]
     
Taiwan     10     11     21  



  Outcome Measures

1.  Primary:   Visual Analogue Scale (VAS) Score for Pruritus   [ Time Frame: VAS score at baseline and after 6 -week phototherapy ]

2.  Secondary:   Detailed Questionnaire at Baseline and After 18 Sessions   [ Time Frame: at baseline and after 18 sessions ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small numbers of subjects analyzed  


Results Point of Contact:  
Name/Title: Ko Mei-Ju
Organization: Dermatology
phone: 886-223123456 ext 2141
e-mail: kmjmay@gmail.com


No publications provided by National Taiwan University Hospital

Publications automatically indexed to this study:

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