Realisierung eines tragbaren dOFM Systems für klinische pharmakologische Studien

Dermal open flow microperfusion (dOFM) is a minimally invasive method for pharmacokinetic (PK) and pharmacodynamic (PD) drug trials in the skin. The aim of this work is (i) the development of missing accessories based on the CE-certified dOFM probe, tubing set and pump and (ii) their evaluation in a clinical PK/PD study with particular attention to standardization and reproducibility.

The developed accessories support every step from the application of the probe to the attachment of the system to the subject. A marking template supports the application the dOFM probe and the topical product, a skin stabilization avoids motion artifacts and the new sampling unit is minimized in size. The establishment of the probe depth measurement using a high-frequency ultrasound system contributes significantly to the standardization. In the final clinical evaluation study a reproducible application and stable sampling over 26 hours was achieved. Pharmacokinetics and pharmacodynamics of study medication clobetasol-17-propionate cream were successfully investigated in the skin.

The dOFM system, now with accessories and standardization tools, forms a reliable basis for future clinical PK/PD studies.