Anti-Pruritic Efficacy of Itch Relief Lotion and Cream in Patients With Atopic History: Comparison With Hydrocortisone Cream

March 2017 | Volume 16 | Issue 3 | Original Article | 243 | Copyright © 2017

Matthew J. Zirwas MD FAADa and Sylvia Barkovic BAb

aOhio Contact Dermatitis Center, Columbus, OH bValeant Pharmaceuticals North America LLC, Irvine, CA

Abstract

Objective: To evaluate the speed of onset and duration of relief of two ceramide-containing formulations with 1% pramoxine hydroxide (CeraVe® Itch Relief Lotion and Cream,Valeant Pharmaceuticals North America LLC, Irvine, CA) in patients with atopic history, including those with active flare and the comparative efficacy of CeraVe Itch Relief Cream to hydrocortisone 1% cream and night-time itch relief with continued use. Methods: Two double-blind, split-body, randomized studies in 66 male and female subjects, ages 11+ years, with history of atopic dermatitis (AD). Itch severity was assessed on a 10-point scale (where 0=none and 7-9=severe). Study one: single applications of ceramide-containing lotion or cream incorporating 1% pramoxine hydrochloride applied to opposite sides of the body. Study two (part 1): single application of ceramide-containing cream or hydrocortisone 1% cream. Study two (part 2): ceramide-containing pramoxine cream applied up to 4 times in a 24-hour period, over the course of 6 days. Itch relief assessed at baseline, 2, and 5 minutes, 1 (2 in study two), 4, and 8 hours post-application. Efficacy and aesthetic attributes were assessed at the same timepoints. Clinical evaluation of performance and mildness of the ceramide-containing 1% pramoxine hydrochloride cream at day 6 (study two, part 2). Results: Study one: Relief of itching was rapid and long-lasting with significant reductions in severity after 2 minutes, and continued improvement over the 8 hour test period (P less than .001 versus baseline at all timepoints). Mean itch severity scores reduced progressively from 6 (moderate) at baseline to 1-2 (mild) after 8 hours, with all patients experiencing relief from itching. Rapid and long-lasting relief to dry, itchy, irritated skin was confirmed through patient self-assessment. Both lotion and cream formulations were non-greasy, absorbed quickly and easily, and were non-irritating. Study two: Ceramide-containing cream incorporating 1% pramoxine hydrochloride provided comparable improvement in itch relief (24.6% reduction in mean itch severity 2 minutes post-application, and 58.0% reduction 8 hours post-application) compared to hydrocortisone cream 1% (18.5% reduction and 59.7% reduction, respectively). Daily use of the ceramide-containing 1% pramoxine cream over 6-days provided all-night relief (87.5% agreement), and perception of skin looking and feeling healthier with each use (71.9% and 81.3% agreement, respectively). Limitations: Results of study one and subsequent comparative study with hydrocortisone 1% cream are based on a single application. There were no placebo controls. Conclusions: Ceramide-containing lotion or cream containing 1% pramoxine provides both rapid and long-lasting relief of itching following a single application in atopic patients with or without active flare. Both formulations were well tolerated with aesthetic appeal. Comparable itch relief to hydrocortisone 1% cream was seen with the ceramide-containing cream over an 8-hour period following a single application. Further ceramide-containing 1% pramoxine hydrochloride cream was well tolerated with continued use over 6 days, delivering comfort and all-night relief for patients with atopic history suffering from reoccurrant itching.

J Drugs Dermatol. 2017;16(3):243-247.

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INTRODUCTION

Atopic dermatitis (AD) is an inflammatory skin disease characterized by intense itching and recurrent eczematous lesions and associated with sleep disturbance, psychological symptoms, and impaired quality of life.1-8 It may be caused by genetic factors,9-11 influenced by environmental factors,12-14 and often starts in childhood.1-3 Most patients with an atopic history have a chronic, relapsing disease course characterized by remission and intermittent ares.15 Atopic dermatitis is a heterogenous disease, including different subtypes with variable clinical manifestations in which the impairments of the skin barrier are crucial. It is characterized by dry skin and increased transepidermal water loss (TEWL). Identification of ceramide as a critical element in barrier function has led to the development of ceramide-based emollients.16-18 These have been shown to be beneficial in reducing TEWL, improving barrier function, and maintaining hydration of the

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