Uremic PruritusNCT00494975
The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease
A study testing Narrow band UVB phototherapy , long wave UVA phototherapy in people with Uremic Pruritus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- Narrow band UVB phototherapy , long wave UVA phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease with moderate to severe uremic pruritus for longer than 2 months
Who cannot join
- pregnancy history of photosensitivity photo-aggravated disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of dermatology, National Taiwan Univeristy Hospital Yun-Lin branch
Douliu, Yunlin County, 640
About this study
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.
Read the 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.
- Conditions
- Uremic Pruritus
- Being tested
- Narrow band UVB phototherapy , long wave UVA phototherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow band UVB phototherapy , long wave UVA phototherapyDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| NB-UVB | Experimental | Narrow band-Ultraviolet B phototherapy Receives: Device: Narrow band UVB phototherapy , long wave UVA phototherapy |
| UVA | Placebo comparator | Ultraviolet A Phototherapy Receives: Device: Narrow band UVB phototherapy , long wave UVA phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: VAS score at baseline and after 6 -week phototherapy
Secondary outcomes (1)
Detailed Questionnaire at Baseline and After 18 Sessions
Measured: at baseline and after 18 sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uremic PruritusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mei-Ju Ko, MD, Principal investigator, Nationa l Taiwan University Hospital Yun-Lin branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494975
- Sponsor's protocol ID
- 200704019R
- Status last verified
- Sep 2010
- First submitted
- 29 Jun 2007
- Last updated
- 27 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 33283264Ko 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.
PubMed 21668425
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00494975
- Acronym / sponsor ID
- 200704019R
- Conditions
- Uremic Pruritus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Jul 2007 (estimated)
- Results
- Posted 25 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NB-UVB | Experimental | Device: Narrow band UVB phototherapy , long wave UVA phototherapyNarrow band-Ultraviolet B phototherapy |
| UVA | Placebo comparator | Device: Narrow band UVB phototherapy , long wave UVA phototherapyUltraviolet A Phototherapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic kidney disease with moderate to severe uremic pruritus for longer than 2 months
Key exclusion criteria (1 listed)
- pregnancy history of photosensitivity photo-aggravated disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrow band UVB phototherapy , long wave UVA phototherapyA 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). | Device | NB-UVB, UVA |
Primary outcome
Visual Analogue Scale (VAS) Score for Pruritus
Time frame: VAS score at baseline and after 6 -week phototherapy
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
1 secondary outcome
Detailed Questionnaire at Baseline and After 18 Sessions
Time frame: at baseline and after 18 sessions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33283264Hercz 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.
- Derived from this study: PubMed 21668425Ko 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.
Related trials for Uremic Pruritus
Active, not recruitingObservational study
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
End-Stage Kidney Disease (ESKD), Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Ju Ko, MD principal investigator
Nationa l Taiwan University Hospital Yun-Lin branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow band UVB phototherapy , long wave UVA phototherapy in people with Uremic Pruritus, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) Score for Pruritus (time frame: VAS score at baseline and after 6 -week phototherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00494975, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2011.