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 © June 2011
Amylynne Frankel MD, Andrew Sohn BS, Rita V. Patel MD, Mark Lebwohl MD
Mount Sinai School of Medicine, Department of Dermatology, New York, NY
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.
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
