A phase IV, randomised, double-blind, controlled, parallel group trial to evaluate the effectiveness and safety of Balneum Plus versus emollient in the treatment of chronic kidney disease–associated pruritus in haemodialysis patients

Abstract

ABSTRACT Background Chronic kidney disease–associated pruritus (CKD-aP) is a common, distressing complaint in patients with advanced renal disease that is frequently overlooked. Treatment is often unsatisfactory. Balneum Plus (Almirall, Barcelona, Spain) is a cream containing 3% lauromacrogols and 5% urea, commonly used to treat atopic dermatitis. It has not been studied in CKD-aP to date. Methods Adult haemodialysis patients were randomised 1:1 to apply Balneum Plus or E45 (Reckitt Beckiser, Slough, UK) to compare the active ingredients of lauromacrogol and urea with a control cream. Itch was defined as three episodes of itching during the last 2 weeks, appearing a few times a day, lasting a few minutes and troubling the patient [1]. Patients with other causes of itch, e.g. eczema and liver disease, were excluded. The primary outcome was a reduction in itch as measured by the visual analogue scale (VAS) score at 4 weeks and analysed using an analysis of covariance approach. Results A total of 314 patients were screened and 58 patients were randomised, 29 in each group. Three patients dropped out in each group. The median baseline VAS scores were 6.5 [interquartile range (IQR) 4.4–8.0] in the Balneum Plus group and 6.3 (IQR 5.1–7.3) in the E45 group. After 4 weeks, VAS scores decreased to 2.6 (IQR 0.9–4.5) and 2.0 (IQR 0.5–4.8) in the Balneum Plus and E45 groups respectively (P = 0.64 for the difference). Using a validated questionnaire to assess secondary outcomes, we found that the Balneum Plus group had longer itching episodes, more difficulty staying asleep and itching was more annoying than in the E45 group. There was no significant difference in adverse events between the two groups. One patient reported inflamed spots on the abdominal skin in the Balneum Plus group. Conclusion This is the first randomised controlled study of two different emollients for the treatment of CKD-aP and is a negative study. We found no significant difference in itch scores between Balneum Plus and E45.