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Introduction
Atopic dermatitis (AD) is a common chronic or recurrent inflammatory skin disorder that starts in early childhood and often precedes the development of other allergic disorders later in life [1, 2]. AD affects 15–20% of children and 1–3% of adults worldwide, and its incidence has increased in industrialized countries over the past few decades [1, 3]. The disease is a significant burden on health-care resources and can limit school or work performance, disturb sleep because of itchiness, and lead to social anxiety and depression [4].
Treatment for AD focuses on repairing or protecting the skin barrier and reducing inflammation and itching. Topical corticosteroids are recommended for treating acute moderate to severe flares, but daily application of an emollient is recommended for preventing and managing AD lesions [2, 5, 6]. Emollients reduce skin dehydration and permeability to irritants, which protects and resolves skin lesions and helps decrease cutaneous reactivity [5, 7, 8–9]. However, many individuals with AD choose not to use emollients as recommended because of the multiple applications required each day and because some emollients have a greasy texture or disagreeable odor [1, 10]. Although many emollients are available, most are cosmetic products designed to improve the appearance of healthy skin and should not be applied to AD skin lesions [5]. By contrast, medical device repairing emollient creams (MDRECs) are suitable for treating and preventing AD. MDRECs for AD should be tested in children because they have AD more frequently, are at increased risk of adverse events (AEs) from topical corticosteroids [11], and have thinner skin than adults [12].
In this study, we examined the tolerability and benefit of a new MDREC in infants, young children, and adults with mild to moderate AD. The MDREC tested is considered a class II medical device [13] and is designed to protect and repair irritated skin, either alone or combined with topical corticosteroids, for individuals at least 3 months of age. The product is formulated free of potential irritant factors and contains natural polysaccharides that form a protective, hydrating invisible film when applied to skin.
Methods
Study Design
This was an open-label, multicenter study in children and adults with mild to moderate AD. The study was performed at six centers in Germany between December 2014 and August...