The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease
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| Tracking Information | |||||
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| First Received Date ICMJE | June 29, 2007 | ||||
| Last Updated Date | January 26, 2011 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT00494975 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Detailed Questionnaire at Baseline and After 18 Sessions [ Time Frame: at baseline and after 18 sessions ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease | ||||
| Official Title ICMJE | The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Uremic Pruritus | ||||
| Intervention ICMJE | 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). |
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| Study Arm (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 21 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00494975 | ||||
| Other Study ID Numbers ICMJE | 200704019R | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | National Taiwan University Hospital | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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