Clinical applicability of dOFM devices for dermal sampling
Publication from Health
Dr Frank Sinner, Manfred Bodenlenz, Aigner B., Dragatin C., Liebenberger L., Zahiragic S., Höfferer C., Dr Thomas Birngruber, Joachim Priedl, MA, Dr Franz Feichtner, Schaupp L., Korsatko S., Maria Ratzer, Dr Christoph Magnes, Prof Dr Thomas Pieber
Skin Research and Technology 19(4):474-483, 2013
Sampling the dermal interstitial fluid (ISF) allows the pharmacokinetics and pharmacodynamics of dermatologicals to be studied directly at their site of action. Dermal open-flow microperfusion (dOFM) is a recently developed technique that can provide minimally invasive, continuous, membrane-free (thus unfiltered) access to the dermal ISF biochemistry. We evaluated the clinical applicability and reliability of novel wearable dOFM devices in a clinical setting.
Physicians inserted 141 membrane-free dOFM probes into dermis of 17 healthy and psoriatic volunteers and sampled dermal ISF for 25h using wearable push-pull pumps. The tolerability, applicability, reproducibility and reliability of multiple insertions and 25h continuous sampling was assessed by pain scoring, physician feedback, ultrasound probe depth measurements and 25h-drift and variability of the sodium relative recovery.
Insertion pain was moderate, and decreased with additional probes. Probe insertion was precise, although slightly deeper in lesional skin. The wearable push-pull pump enabled uninterrupted ISF sampling over 25 h with low variability. The relative recovery was driftfree and highly reproducible.
dOFM sampling devices are tolerable and reliable for prolonged continuous dermal sampling in a multiprobe clinical setting. These devices should enable the study of a wide range of drugs and their biomarkers in the skin.