Uremic Pruritus
Conditions
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.
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.
Interventions
DEVICENarrow 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).
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) Score for Pruritus | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Detailed Questionnaire at Baseline and After 18 Sessions | at baseline and after 18 sessions |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. ) | 10 |
| 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). | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | Narrow Band Ultraviolet B Phototherapy | Ultraviolet A Phototherapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 5 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 5 Participants | 12 Participants |
| Age Continuous | 60.9 years STANDARD_DEVIATION 11.5 | 63.2 years STANDARD_DEVIATION 11.3 | 62.0 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment Taiwan | 11 participants | 10 participants | 21 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
Primary
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
Time frame: VAS score at baseline and after 6 -week phototherapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultraviolet A Phototherapy | Visual Analogue Scale (VAS) Score for Pruritus | -3.38 Units on a scale | Standard Deviation 2.59 |
| Narrow Band Ultraviolet B Phototherapy | Visual Analogue Scale (VAS) Score for Pruritus | -3.53 Units on a scale | Standard Deviation 3.49 |
Comparison: The VAS score of pruritus intensity was recorded for each participant at baseline and weekly until week 12 so that each one had 12 repeatedly measured data scores. To investigate the predictive effects of age, sex, comorbid diseases, phototherapy, and results of blood laboratory exams on the intensity of pruritus, marginal linear regression model was fitted to the repeatedly measured VAS score data using the generalized estimating equations (GEE) method.p-value: <0.0595% CI: [0.31, 1.56]generalized estimating equations (GEE)
Secondary
Detailed Questionnaire at Baseline and After 18 Sessions
Time frame: at baseline and after 18 sessions