RESUMO
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.
