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Skin Deep

The safety battery for topically applied products typically includes evaluation of the final to-be-marketed formulation for cutaneous toxicity (most notably dermal irritation) potential for inducing contact sensitisation and photoallergic contact sensitisation, and phototoxic potential. Even though these Phase I safety studies are an integral part of almost every topical development programme and help lay the groundwork for responsible and safe clinical development in later phases, there are no current FDA or EMEA guidelines specific to these studies. Unfortunately, in the absence of guidelines setting down the requirements and designs for these studies, sponsors are often at a loss for rational designs and to manage agency expectations. This article presents an overview of the basic study designs for standard dermal safety tests in humans.


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Betsy Hughes-Formella is Director of Business Development and Consulting at bioskin GmbH. She received her MS and PhD in Physiology from the University of Georgia, Athens, before moving to Germany to join a research team at the University Medical Center in Hamburg. Betsy’s research interests were in the areas of steroid biochemistry and the pathogenesis of melanoma. She joined bioskin in 1993. In her current role, she is responsible for the coordination of the company’s business development activities and is a consultant and advisor for clinical development concepts and study designs.

Joachim Fluhr has been Medical Director at bioskin GmbH since 2007. He received his MD at Johannes-Gutenberg-University of Mainz, Germany, and was trained in dermatology at the Department of Dermatology, Karlsruhe, Germany. He is a board-certified dermatologist. Joachim performed clinical trials in Karlsruhe and Pavia, Italy, before joining the UCSF-based team of Peter Elias in San Francisco for two years. After returning to Germany he was an attendant at the Friedrich-Schiller-University of Jena where he also headed the Skin physiology Laboratory for over four years. Currently, Joachim also holds a position as adjunct Lecturer in the Department of Dermatology, Charité, Berlin.

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Betsy Hughes-Formella
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Joachim Fluhr
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