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.
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