Efficacy of a moisturizer for pruritus accompanied by xerosis in patients undergoing dialysis: A multicenter, open-label, randomized verification study.

Yukie Yoshida,Akira Kanakubo,Momoyo Kishida,Hiroshi Nakamura,Hidehisa Saeki,Noritsugu Yokota,Kazumasa Hashimoto,Shuichi Tsuruoka,Akio Hirama,Takeshi Sato

doi:10.1111/1346-8138.15950

Abstract

Xerosis and pruritus are common in patients undergoing dialysis. These symptoms are treated with moisturizers, but limited evidence supports the efficacy of such treatment. Our exploratory study suggested the effectiveness of a heparinoid‐containing product for xerosis in dialysis patients. We conducted a multicenter, open‐label, randomized, before‐after, parallel‐group comparative study to verify the exploratory study results (Clinical Trial Registry: UMIN000029360). Seventy‐one Japanese patients undergoing dialysis with chronic kidney disease and xerosis were randomly assigned to receive a heparinoid‐containing product for 2 weeks (group A [n = 36]) or 8 weeks (group B [n = 35]). Patients were instructed to apply the study product based on the fingertip unit method. The efficacy endpoints were the water content of the stratum corneum (WCSC), skin dryness score, pruritus visual analog scale score, and Dermatology Life Quality Index. Safety was assessed by monitoring adverse events. The mean WCSC (arbitrary units) was 26.0 ± 9.6 in group A and 25.2 ± 10.0 in group B at the start of treatment (week 0), significantly increased to 39.0±12.5 in group A and 38.5 ± 11.0 in group B (P < 0.0001 for both vs week 0) by week 2, and then decreased only in group A. Thus, the WCSC at week 4 (the primary endpoint) remained significantly higher in group B (36.4 ± 12.2 vs 28.8 ± 10.4; P = 0.0068). Other endpoints improved during treatment with the study product. One patient developed a rash and erythema as treatment‐related adverse events. In conclusion, 8 weeks’ application of a heparinoid‐containing product was effective for xerosis in patients undergoing dialysis.

Highlights

Dry skin is observed in 50%–90% of patients with end-stage renal disease and persists or even worsens despite dialysis.[1]
Heparinoid-containing products are widely used for xerosis caused by various factors, including dialysis, in Japan
We investigated the time course of the severity of skin dryness and associated changes in pruritus and quality of life (QOL) with comparison between two groups undergoing different lengths of treatment and with an adequate sample size set based on preceding exploratory study results on the water content of the stratum corneum (WCSC) at week 4.13

Summary

Introduction

Dry skin is observed in 50%–90% of patients with end-stage renal disease and persists or even worsens despite dialysis.[1] Pruritus is reported in 12%–90% of patients with end-stage renal disease.[1] Suggested causes of pruritus in patients with end-stage renal disease undergoing dialysis include dry skin, the influence of dialysis membranes, and the effect of increased circulating pruritic cytokines.[2,3] A descriptive study of the risk factors for pruritus in patients undergoing dialysis revealed more intense pruritus in patients with dry skin than in those with normal skin.[4] a greater number of dermatoses and longer duration of dialysis are reportedly associated with poorer scores on the Dermatology Life Quality Index (DLQI),[5] a tool used to measure the quality of life (QOL) related to skin disease.[6] For pruritus in particular, greater severity is reportedly associated with poorer QOL7 and higher mortality.[8]

Methods

Results

Conclusion