Bilateral Comparison Study of Pimecrolimus Cream 1% and a Ceramide-Hyaluronic Acid Emollient Foam in the Treatment of Patients With Atopic Dermatitis

June 2011 | Volume 10 | Issue 6 | Original Article | 666 | Copyright © 2011

Abstract

Topical corticosteroids have been the mainstay of treatment for atopic dermatitis (AD) over the last decade, especially in the setting of acute flares. However, heavy and prolonged use of topical corticosteroid is undesirable as it is associated with side effects such as, skin atrophy, telangiectasia, striae, steroid-induced dermatoses, rosacea, acne exacerbation, and in some severe and rare cases, systemic effects such as hypothalamic-pituitary-adrenal axis suppression, growth retardation and ocular problems. Non-steroidal antinflammatory agents specific for the treatment of AD (topical calcineurin inhibitors, or TCIs) are now available and they are a viable alternative to topical corticosteroids in treating dermatitis of the face, neck, eyelids, and intertriginous areas where there is a greater risk of the steroid-induced side effects. More recently, medical device emollients have entered the marketplace. These medical devices provide, but are not limited to, anti-oxidant, anti-protease, anti-inflammatory activity, and aid in restoring the natural balance of lipids, which is one of the causes of the epidermal abnormalities seen with AD. The present study evaluated the short-term effectiveness and appeal of a non-steroidal medicated device foam as compared to pimecrolimus cream 1% in the treatment of AD within a wide age group of subjects with active disease at baseline. In this study, both pimecrolimus and the medical device foam exhibited efficacy in mild-to-moderate AD. Primary efficacy was measured by IGA. After four weeks of treatment with the medical device foam, 82% of target lesions were scored "clear" (0) or "almost clear" (1) compared to 71% of target lesions under the pimecrolimus arm. This study confirmed that pimecrolimus cream 1% and the medical device foam work well in the treatment of AD in both adults and children with no associated adverse effects.

J Drugs Dermatol. 2011;10(6):666-672.

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INTRODUCTION

Atopic dermatitis (AD) is a chronically relapsing, inflammatory skin disease arising from a complex interplay among genetic, environmental, immunological, and biochemical factors. AD affects 1-3 percent of the adult population and 10-20 percent of children in industrialized countries.1,2 Over the last few years, AD has been increasing in prevalence, suggesting that an additional environmental cause is also at play.3,4 Although many genes that alter the epidermis have been identified as contributors to the pathogenesis of AD, disturbed barrier function and altered immunity are also considered to be major factors in the development of this disease. Therefore, much attention has been focused on improving the impaired epidermal barrier function which is a hallmark feature of AD.

The epidermal barrier function is largely regulated by the stratum corneum (SC), which is composed of protein enriched corneocytes and lipid-enriched intercellular domains. The SC provides a permeability barrier that is not only antimicrobial and antioxidative in nature but which also filters ultraviolet (UV) light while regulating skin moisture.5 Additionally, the SC protects the body against physical and chemical injury and prevents loss of body water and other substances. The presence of water in the SC is of key importance in regards to preserving its flexibility and elasticity.6

In AD, analysis of the lipid content has revealed a decrease in three essential lipids (ceramide, cholesterol, long-chain free fatty acid) found within the SC, which are critical for normal permeability barrier function.7 This SC lipid deficiency reduces barrier function, which induces transepidermal water loss (TEWL). TEWL produces micro-fissures, scaling, erythema, and weakens the physical barrier against the penetration

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