Efficacy of a Moisturizer for Pruritus Accompanied With Asteatosis in Dialysis Patients: An Open-Label, Randomized, Exploratory Study

Abstract

Background In dialysis patients, skin disorders (dryness and itching) are frequently observed and treated with a moisturizer, in the absence of clear evidence of efficacy. Study Design An open-label, randomized, before/after, parallel-group, comparative/exploratory study. Setting & Participants 12 Japanese patients with chronic kidney failure undergoing maintenance hemodialysis who presented with dry skin and itching. Intervention Patients received a topical heparinoid moisturizer as the study drug for 2 weeks from the first day of the study treatment, followed by either a 2-week washout (group A: 6 participants) or further 2-week treatment (group B: 6 participants). Outcomes The primary end point was change in water content in the stratum corneum in the hypochondrium. Secondary end points included change in visual analogue scale itching score and subjective evaluations of symptoms. To evaluate safety, adverse events were also investigated. Measurements Water content of the stratum corneum, dryness/itching improvement rating, itching visual analogue scale/duration of itching, photographic evaluation of skin symptoms, principal investigator’s overall assessment of study drug, and adverse events. Results Mean water content of the stratum corneum in the combined groups significantly increased at week 2 (51.2 arbitrary units [AU] vs treatment start day, 31.6 AU; P <0.001), but significantly decreased at week 4 in group A, in which patients discontinued treatment with the study drug (39.4 AU; P = 0.005). Other efficacy end points, including the visual analogue scale itching score, were also improved by treatment with the study drug, but such improvement was not sustained after discontinuation of treatment. There were no adverse events related to the study treatment. Limitations Only Japanese patients were included in the study, with a small sample size. Conclusions Continuous application of the topical heparinoid moisturizer increased water content in the stratum corneum and lessened itching in dialysis patients. Funding Maruho Co, Ltd. Trial Registration Registered at the University Hospital Medical Information Network Clinical Trials Registry with study number UMIN000017016.

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

“…Heparinoid-containing products are widely used for xerosis caused by various factors, including dialysis, in Japan. However, no reports other than our previous study 13 In this study, xerosis measured by WCSC and skin dryness score improved from week 1 of application of the heparinoid-containing product and worsened from 1 week after discontinuation of the application. Additionally, between the two groups of patients who continued and discontinued application of the heparinoid-containing product, the WCSC at week 4 (primary endpoint) and all other time points of evaluation after week 3 showed significant differences.…”

“…Patients were excluded if they had used any moisturizer (heparinoid‐containing products, urea preparations, or petrolatum) within 3 weeks before the scheduled start day of the study treatment, had a history of allergy to any heparinoid‐containing product, or were otherwise ineligible for this study in the opinion of the investigator. The target sample size was set to 38 participants per group based on the results of our preceding exploratory study, 13 assuming an intergroup difference of 7.61 in the mean WCSC at week 4 (the primary endpoint of this study) with a standard deviation of 9 for both groups, a 1:1 randomization ratio, a 5% two‐sided significance level, 90% power, and allowance for a 20% dropout rate.…”

“…One site in either the left or right hypochondriac region was designated as the measurement site for each participant. The measurement was conducted using the same instrument as in the previous study 13 (Corneometer and Multi Display Devices MDD4; Courage + Khazaka Electronic GmbH, Köln, Germany). Measurement of the WCSC by the corneometer is based on the electrical capacitance of the skin surface (at approximately 15 µm depth) and values ranging from 0 to 120 arbitrary units (AU) were delivered.…”

“…One site in either the left or right hypochondriac region was designated as the measurement site for each participant. The measurement was conducted using the same instrument as in the previous study 13…”

“…We previously conducted an exploratory study of 12 patients with chronic kidney disease and xerosis undergoing hemodialysis, and the results suggested the effectiveness of a moisturizer for xerosis and associated pruritus in these patients. 13 In that study, we evaluated 2‐week (group A) versus 4‐week (group B) application of a heparinoid‐containing product with weekly measurement of the water content of the stratum corneum (WCSC). The WCSC increased in both groups up to week 2 and was then maintained in group B up to week 4, but decreased in group A after week 2.…”