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Clinical applicability of dOFM devices for dermal sampling.

M Bodenlenz¹, B Aigner, C Dragatin

¹HEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H., Graz, Austria.

Skin Research and Technology : Official Journal of International Society for Bioengineering and the Skin (ISBS) [And] International Society for Digital Imaging of Skin (ISDIS) [And] International Society for Skin Imaging (ISSI)

|April 16, 2013

Summary

Novel wearable dermal open-flow microperfusion (dOFM) devices provide tolerable and reliable continuous sampling of dermal interstitial fluid (ISF). These devices enable in-depth skin drug and biomarker studies in a clinical setting.

Keywords:

bioequivalence cutaneous human in vivo interstitial fluid open-flow microperfusion pharmacodynamics pharmacokinetics push-pull tolerability

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Area of Science:

Dermatology
Pharmacokinetics
Biomedical Engineering

Background:

Dermal interstitial fluid (ISF) sampling is crucial for studying dermatological drug pharmacokinetics and pharmacodynamics.
Dermal open-flow microperfusion (dOFM) offers minimally invasive, continuous, and unfiltered ISF access.
Evaluation of novel wearable dOFM devices for clinical use is needed.

Purpose of the Study:

To assess the clinical applicability and reliability of new wearable dOFM devices.
To determine the tolerability and reproducibility of prolonged ISF sampling.
To investigate the feasibility of multiprobe dOFM in a clinical environment.

Main Methods:

141 membrane-free dOFM probes were inserted into the dermis of 17 volunteers (healthy and psoriatic).
Wearable push-pull pumps were used for 25-hour continuous ISF sampling.
Tolerability, applicability, reproducibility, and reliability were assessed via pain scoring, physician feedback, ultrasound, and sodium relative recovery drift/variability.

Main Results:

Moderate insertion pain, decreasing with subsequent probes; precise insertion, slightly deeper in lesional skin.
Uninterrupted 25-hour ISF sampling achieved with low variability using wearable pumps.
Highly reproducible and drift-free sodium relative recovery confirmed the reliability of the dOFM technique.

Conclusions:

Wearable dOFM sampling devices are tolerable and reliable for extended continuous dermal sampling in multiprobe clinical settings.
These devices facilitate the investigation of diverse drugs and their biomarkers within the skin.
dOFM technology holds promise for advancing dermatological research and drug development.