Clinical applicability of dOFM devices for dermal sampling

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.