Tolerability and Cosmetic Acceptability of a Body Wash in Atopic Dermatitis-Prone Subjects

September 2014 | Volume 13 | Issue 9 | Original Article | 1108 | Copyright © 2014

Staci Brandt PA-C MBA MS,a Matthew H. Meckfessel PhD,a and Peter A. Lio MDb

aGalderma Laboratories, L.P., Fort Worth, TX
bNorthwestern University Feinberg School of Medicine, Chicago, IL

Abstract

Atopic dermatitis is a common skin disease characterized by eczematous eruptions and impaired skin barrier function. Patients, as well as their families, frequently report reductions in quality of life. Pruritus, lack of sleep, and impaired social functioning all contribute to this reduction. A skincare regimen of gentle cleansing and daily moisturization is integral to managing atopic dermatitis. While there are a multitude of reports supporting the use of moisturizers, there is a paucity regarding the use of cleansers, especially cleansers formulated with ingredients known to improve skin hydration. A clinical study was conducted to assess the tolerability and cosmetic acceptability of a body wash formulated with the filaggrin break-down products arginine and pyrrolidone carboxylic acid in subjects with atopic dermatitis-prone skin (Cetaphil® RestoraDerm® Body Wash). The results of this study indicate that Cetaphil RestoraDerm Body Wash was well tolerated, reduced itch, improved quality of life, and was well-liked by subjects with atopic dermatitis-prone skin.

J Drugs Dermatol. 2014;13(9):1108-1111.

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INTRODUCTION

Atopic dermatitis is a common skin disease that affects up to 18% of the US pediatric population.1 Beyond the characteristic eczematous eruption, patients with atopic dermatitis may present with elevated serum IgE levels, xerosis, keratosis pilaris, and food intolerance, among others.2,3 The skin of atopic dermatitis patients is characterized by impaired skin barrier function, specifically reduced hydration and increased transepidermal water loss.4 Mutations in the filaggrin (FLG) gene and subsequent reduction in natural moisturizing factor as well as altered ceramide content are believed to be contributing factors.5-10 The skin of atopic dermatitis patients also has increased of Staphylococcus aureus colonization rates, which further indicates deficient skin barrier function.11

Atopic dermatitis negatively affects quality of life for both patients with atopic dermatitis as well as their caregivers.12 Pruritus is often the first symptom of atopic dermatitis mentioned by parents of children with atopic dermatitis that has a negative effect on quality of life and is inversely correlated with quality of life.13 Patients with atopic dermatitis also report difficulty sleeping as well as increased psychological stress.12 This sleep disruption has led many patients and their families to not only report lower quality of life, but also that the excoriations and exacerbation of skin disease occurring during the night can be distressing.14 Additionally, patients may struggle with embarrassment and impaired social functioning.12

A good skincare regimen of cleansing and moisturizing is fundamental to managing atopic dermatitis. Gentle cleansers that do not harm the skin barrier are recommended.15 These cleansers should consist of non-soap based surfactants formulated at a neutral to acidic pH, which helps to provide cleansing benefits without damaging skin barrier integrity.15 Moisturizers also help to hydrate the skin and restore skin barrier function.16,17 Newer formulations have incorporated ceramides and filaggrin breakdown products to help replenish components necessary for skin barrier function.18-21 Long-term atopic dermatitis management includes the use of flare prevention strategies, which includes routine daily skin moisturization.19

While atopic dermatitis is frequently treated with topical corticosteroids, it may be possible to minimize the need for corticosteroids through moisturizer use and improved skin hydration. 22 However, it is unknown, what effect cleansers formulated with ingredients known to provide moisturization benefits may have in patients with atopic dermatitis-prone skin. The literature is replete with data supporting the use of moisturizers for atopic dermatitis patients, but there is a paucity of literature regarding the importance of cleansers in this population.

The present clinical study was designed to assess the performance and cosmetic acceptability of a body wash (Cetaphil® RestoraDerm® Body Wash; Galderma Laboratories, L.P.) for-

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