Evaluation of the effectiveness and safeness of a new formulation of cold cream in patients with atopic dermatitis

Abstract

Atopic dermatitis (AD) or atopic eczema is a chronic inflammation of the skin generally associated with atopy. The most common symptoms are intense pruritus in specific parts of the skin and eczematous lesions with cyclic evolution in periods of worsening and improvement. The absence of a safe and effective treatment, taking into account the chronic nature of AD, highlights the importance of new therapeutic alternatives. Therefore, the topical application of cream base, which is a cream without drugs, has attracted attention as it is possible to improve the course of the disease with less use of corticosteroids. The Cold Cream, one of the oldest dermatological pharmaceutical preparations has been successfully used in clinical practice for AD; however, it has few studies in scientific literature. Significant improvement of the erythematous lesions (decrease in the lesion depth and increase in skin hydration) has been noticed in patients using this emulsion when compared to the untreated ones. Since 1979, the Pharmacy Teaching Department of the School of Pharmaceutical Sciences of Ribeirão Preto at University of São Paulo has used the Cold Cream for treating patients with AD at Hospital das Clínicas de Ribeirão Preto. Approximately two years ago, the officinal formulation (originally distributed) was modified in order to increase its shelf life. The new formulation, named Cold Cream M., presents in its composition agents of consistency and stabilizers; it also has less processed beeswax and due to this, it is consequently composed by different mixture of acids and fatty alcohols. There was an increase in production demand when distributing Cold Cream M. to replace the officinal Cold Cream. Patients also reported significant improvement of the signs and symptoms characteristic of the disease. The hypotheses suggested to explain the improvement of AD are related to improvements in the mechanics, texture and rheology of the cream which resulted in greater acceptance by the patient; greater replacement of the fatty content of the stratum corneum with increased barrier properties of the skin and; influence of propolis, which may be present in the less processed beeswax and may contribute to the anti-inflammatory, antioxidant and antimicrobial activity of the cream. The present work aims to prepare and characterize three different Cold Cream formulations, the traditional one, Cold Cream M. and Cold Cream M. added with propolis, and investigate their influence on the inflammatory response and appearance of lesions in vivo. (AU)