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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: |
