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Atopiclair Nonsteroidal Cream

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... Telmesteine has also been shown to possess free radical-scavenging activities. In a small, randomized, double-blind, vehicle-controlled trial with 20 subjects, this cream was superior to the vehicle in improving the sodium lauryl sulfate-induced irritant contact dermatitis as mea sured by param e ters such as the transepidermal water loss (22) [LOE-B]. A Eu ro pe an randomized, double-blind, vehicle-controlled study with 30 adult AD patients suffering from mild to moderate AD revealed that the above cream is safe and effective in the treatment of AD (20) [LOE-A]. ...
Article
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Chapter
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Atopiclair (Zarzenda) is a topical non-steroidal anti-inflammatory agent for the treatment of allergic diseases of the skin. Three main ingredients are contained in this product: glycyrrhetinic acid, telmesteine and Vitis vinifera extracts. Other ingredients include: allantoin, alpha-bisabolol, capryloyl glycine, hyaluronic acid, shea butter and tocopheryl acetate. Two previous randomized, double-blind, vehicle-controlled clinical studies provided evidence that Atopiclair is effective in the treatment of atopic dermatitis. This article presents an open, multicenter, sponsor-free, study on the anti-pruritic activity of this product in adult patients with mild-to-moderate atopic dermatitis. The Median Visual Analogue Scale (VAS) values were: at the start of the study (TO), median VAS was 48.5 mm; three weeks later (T1), median VAS was 34.1 mm (-14.4 mm from baseline); six weeks later (T2), median VAS was 24.6 mm (-23.9 mm from baseline). Statistical analysis revealed that differences between TO versus T1, TO versus T2 and T1 versus T2 were highly significant (p<0.001). Side effects (local burning) were relatively common, although mild in severity. On the basis of the results of this study, Atopiclair showed efficacy in relief of pruritus in adult patients with mild-to-moderate atopic dermatitis.
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MAS063DP (Atopiclair) is a topical cream approved for symptomatic relief in the treatment of atopic and contact dermatitis. This was a multicenter, randomized, double-blind, vehicle-controlled study in adults with mild-moderate atopic dermatitis. Patients were given MAS063DP or vehicle (2:1) three times per day to areas affected by atopic dermatitis for up to 50 days. A patient global assessment change from baseline was determined at days 8, 22, 36, and 50. Patient total body pruritus (visual analog scale) and patient opinion on treatment acceptability were also assessed. A total of 218 patients (active: n = 145, vehicle: n = 73) were enrolled. At Day 22, 77% of patients on MAS063DP had a patient global assessment of good improvement or better versus 21% on vehicle (p<0.0001, chi-squared test). Similarly, more patients had improvement in itch over their total body on MAS063DP than on vehicle (p<0.0001). MAS063DP treatment results in patient-perceived improvements in mild-moderate atopic dermatitis.
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The classic role of topical and systemic corticosteroids for allergic dermatoses is discussed, with special attention to the impact on the current clinical treatment paradigm by newer systemic and topical therapies. These products are reviewed and recommendations presented on how to effectively assimilate them into clinical practice. Current knowledge about the etiopathogenesis of atopic dermatitis has resulted in drug development focused on agents with less toxicity than current topical and systemic corticosteroids. Some agents with ceramide/cholesterol/acid combinations demonstrate efficacy in restoring the dysfunctional skin barrier of atopic patients. Concerns resulting from the recent Federal Drug Administration announcement regarding a theoretical risk of cancer associated with topical calcineurin inhibitors are also addressed. Novel therapeutic entities are presented. Patients seeking relief from atopic dermatitis have historically had few really effective and safe therapeutic options. Topical calcineurin inhibitors represent an exciting new therapy for atopic dermatitis without the side-effect profile associated with topical corticosteroids. Nonsteroidal formulations incorporating glycyrrhetinic acid/telmesteine/Vitis vinifera extract and palmitoylethanolamide as 'active' ingredients recently entered the market, stressing antipruritic, antiinflammatory, and skin barrier repair. This confabulates against previously designed topical therapy paradigms. These new products may be used as monotherapy or alternatives to steroid agents.
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Atopic dermatitis (AD) is a chronic inflammatory disease hypothesized to be the product of complex interactions among the host's environment, susceptibility genes, skin barrier dysfunction, and immune system dysregulation. The objective of this article is to describe the pathobiology and treatment of AD, with particular focus on the role of immune system dysregulation and therapies designed to target this. Literature review indicates that there are immunologic differences between the lesional and non-lesional skin of atopic individuals, and that the non-lesional skin of atopic individuals presents an immunologic profile distinct from that of the skin of healthy individuals. Thus, immune system dysregulation is postulated to be a key contributing factor to the complex etiology of AD. Immunomodulatory agents such as topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs), which address the underlying immunopathology of AD, are the foundation for the pharmacologic treatment of flares. TCSs and TCIs both target the inflammatory response responsible for an AD flare but via two distinct mechanisms of action. Whereas TCSs have a more widespread impact on the immune system, the action of TCIs is targeted to the calcineurin pathway and inhibition of T-cell activation. Together, TCSs and TCIs represent the backbone of a long-term treatment strategy for AD.
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