A Randomized Controlled Clinical Trial Comparing the Efficacy of Dead Sea Mineral-Enriched Body Lotion versus Two Types of Placebo in the Treatment of Cutaneous Dryness, Itching, Peeling and Tightness in Hemodialysis Patients (EDIT)

Abstract

Background/Aims: The present study was designed to investigate the short-term safety and efficacy of topical application with body lotion enriched with minerals from the Dead Sea versus 2 different placebo treatments in reducing symptoms of uremic pruritus. Methods: In this single-center, randomized, double placebo-controlled clinical trial, 78 hemodialysis patients with self-reported uremic pruritus were randomized to twice-daily topical treatment with body lotion enriched with minerals from the Dead Sea (DS) or to each of 2 types of placebo: (1) lotion with no Dead Sea minerals but otherwise identical to DS (P1) or (2) lotion with no active ingredients (P2). Symptoms of uremic pruritus (itching, dryness, peeling, tightness) were evaluated at baseline and 2 weeks (14 days) after treatment intervention using a 5-point Likert scale. Results: Following treatment, significant differences in symptom severity scores between DS and P1 and, separately, between group DS and P2, were not detected. Additionally, when DS was compared to the combined placebo groups (P1 and P2 together), significant post-treatment differences in symptom severity scores were not observed. Symptoms were less severe post-treatment regardless of treatment assignment. Conclusions: DS was not superior to either of the placebo treatments in the symptomatic relief of uremic pruritus.

Chronic kidney disease‐associated pruritus in patients undergoing hemodialysis: Xerosis and topical therapy

“…However, almost all active ingredients used as topical treatment in these studies were shown to significantly reduce pruritus intensity, except Tacrolimus ointment 0.1% 69 and Dead Sea (DS) minerals. 72 In studies that measure skin dryness/skin hydration as one of the outcomes, these various topical forms (gels, creams, emulsions, lotions, and solutions) can also reduce skin dryness or improve skin hydration. 68,70,75,76,78,80,84,85,87 Topical drug preparations consist of active ingredients (drugs) in a base (vehicle), and excipients (e.g., emulsifiers, antioxidants, and preservatives).…”

Chronic Kidney Disease-Associated Pruritus: A Review

“…Cold receptor agonists, such as menthol (activating cold receptors in the skin has an antipruritic effect) [50] and topical cannabinoids (activating endocannabinoid receptors in the skin has an antipruritic effect) [51]. Lack of efficacy was demonstrated for the following agents in regard to management of CKD-aP: topical calcineurin inhibitors tacrolimus 0.1% [52] and pimecrolimus 1% [53], and dead sea mineral-enriched body lotion [54].…”

Systemic causes of non‐dermatologic chronic pruritus in the pediatric population and their management: An unexplored area

“…Of the topical treatments, GLA-enriched cream and 1% pramoxine were significantly more effective when compared to placebo. [69][70][71][72][73][74][75][76] We also use a combination of ketamine 5%-10%, lidocaine 5%, and amitriptyline 5% compounded in Lipoderm® for severely itchy areas, as this formulation inhibits ion channels and NMDA receptors in the skin. 77,78…”