Clinical applicability of dOFM devices for dermal sampling
Publication from Health
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.