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Original ArticlesClinical Nephrology
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Randomized, Double-blind Study with Glycerol and Paraffin in Uremic Xerosis

Elias Balaskas, Jacek C. Szepietowski, Didier Bessis, Dimitrios Ioannides, Claudio Ponticelli, Corinne Ghienne, Alain Taberly and Patrick Dupuy
CJASN April 2011, 6 (4) 748-752; DOI: https://doi.org/10.2215/CJN.05490610
Elias Balaskas
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Jacek C. Szepietowski
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Didier Bessis
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Dimitrios Ioannides
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Claudio Ponticelli
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Corinne Ghienne
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Alain Taberly
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Patrick Dupuy
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    Figure 1.

    Time-course severity score of uremic xerosis in the study population (n = 99). *P < 0.001 (intragroup analysis).

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    Figure 2.

    Evolution of the severity of uremic pruritus under treatment in the study population (n = 99). *P < 0.0001 (intragroup analysis).

Tables

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    Table 1.

    Demographic features and health status of the study population at baseline

    Variablesn = 99
    Age (years, mean ± SEM; range)63.16 ± 1.28; 18–89
    Gender (n, %)
        male53 (54%)
        female46 (46%)
    End-stage renal disease underlying disease (n, %)
        glomerular diseases25 (25%)
        diabetic nephropathy15 (15%)
        nephrosclerosis15 (15%)
        polycystic kidney14 (14%)
        congenital nephropathies1 (1%)
        pyelonephritis5 (5%)
        hypertensive nephropathy7 (7%)
        others9 (9%)
        unknown10 (10%)
    Type of MRD (n, %)
        hemodialysis90 (91%)
        peritoneal dialysis9 (9%)
    Duration of MRD (years, mean ± SEM)7.91 ± 0.71
    Duration of xerosis (years, mean ± SEM)5.4 ± 0.53
    Clinical severity of xerosis (n, %)
        mild2 (2%)
        moderate50 (51%)
        severe to very severe47 (47%)
    Total clinical score of xerosis (mean ± SEM)8.3 ± 0.3
    Association with pruritus (n, %)
        yes74 (75%)
        no25 (25%)
    Severity of pruritus (mm VAS, mean ± SEM)40.64 ± 3.36
    Quality of life scores (mean ± SEM)
        PCS30.51 ± 1.21
        MCS41.29 ± 1.24
        DLQI5.61 ± 0.57
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    Table 2.

    Comparison of uremic xerosis severity on the lower legs between the two treatment groups after 7 days (Period I) in the study population (intent-to-treat analysis)

    Study ParametersTest Product (n = 99)Comparator (n = 99)P
    Treatment response (n, %)
        yes72 (73%)44 (44%)<0.0001
        no27 (27%)55 (56%)
    Instrumental severity of xerosis (arbitrary units, mean ± SEM)
        SURFT
            baseline11.37 ± 0.6410.25 ± 0.55
            day 73.19 ± 0.425.35 ± 0.57<0.0001
        MOD
            baseline19.20 ± 0.9818.02 ± 0.76
            day 77.83 ± 0.6011.56 ± 0.93<0.0001
    Test side preference
        clearly better6013<0.0001
        comparable2626
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Clinical Journal of the American Society of Nephrology: 6 (4)
Clinical Journal of the American Society of Nephrology
Vol. 6, Issue 4
1 Apr 2011
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Randomized, Double-blind Study with Glycerol and Paraffin in Uremic Xerosis
Elias Balaskas, Jacek C. Szepietowski, Didier Bessis, Dimitrios Ioannides, Claudio Ponticelli, Corinne Ghienne, Alain Taberly, Patrick Dupuy
CJASN Apr 2011, 6 (4) 748-752; DOI: 10.2215/CJN.05490610

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Randomized, Double-blind Study with Glycerol and Paraffin in Uremic Xerosis
Elias Balaskas, Jacek C. Szepietowski, Didier Bessis, Dimitrios Ioannides, Claudio Ponticelli, Corinne Ghienne, Alain Taberly, Patrick Dupuy
CJASN Apr 2011, 6 (4) 748-752; DOI: 10.2215/CJN.05490610
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