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New Trends in Dermatology Clinical Research

In dermatology it is often possible to establish clinical efficacy before committing to a full clinical and safety programme. This is because the focus of dermatology - the skin - is directly accessible for therapy. In contrast to systemic or topical application to large areas, in many cases a very small treatment area can be selected for dosing of topical therapies, effectively eliminating risks associated with systemic exposure.

Dermatology offers a unique opportunity for simultaneous evaluation of multiple formulations/actives in intra-individual comparison using special efficacy models, either in healthy or 'symptomatic' volunteers. The parallel comparison of various formulations in one individual is able to provide reliable decision criteria in shorter time spans on relatively small panels. In these models the use of modern bioengineering methods provides alternative objective endpoints to support clinical evaluation, giving additional information on structural and functional changes in the skin.

One of the major aims of dermatological therapy is anti-inflammatory efficacy. Clinical symptoms of inflammation may include erythema, infiltrate or edema, pain or itching. Skin barrier damage usually accompanies the inflammatory reaction. There are a number of well-established methods to quantify the extent of the inflammatory response:


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By Dr Betsy Hughes-Formella, Managing Director at Bioskin GmbH

Dr Betsy Hughes-Formella received her PhD in Physiology from the University of Georgia in Athens, Georgia in 1983. She moved to Germany to join a research team at the University Medical Center in Hamburg. Her research interests were in the area of steroid receptors in the neuromuscular system and later in the pathogenesis of melanoma. In 1992 Dr Hughes joined Bioskin GmbH as Managing Director. In her current capacity she consultants and advises on clinical development concepts and study designs for Bioskin sponsors. In addition, she is responsible for the co-ordination of the company's business development and strategic alliance opportunities. She is an active member of several scientific societies, including a position on the board of regents of the German Association of Applied Human Pharmacology (AGAH) and the working group for dermocosmetics in the German Association for Dermopharmacie (GD).
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Dr Betsy Hughes-Formella
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