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.

SUBMITTER: Yoshida Y 

PROVIDER: S-EPMC7380392 | biostudies-literature | 2019 Jul-Aug

REPOSITORIES: biostudies-literature