NCT03813030

An Exploratory Study in Healthy Volunteers to Investigate the Cross-talk Between Local Drug Concentrations in the Skin and Systemic Concentrations During Topical Bioequivalence Studies Using Dermal Sampling Techniques

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Joanneum Research Forschungsgesellschaft mbH · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a single center, open label, exploratory research study to assess the dermal and systemic PK of marketed products of lidocaine/prilocaine in 26 healthy participants using dermal open flow microperfusion (dOFM) and microdialysis (MD) for dermal sampling. The clinical study aims to identify potential cross-talk between the extracellular compartments of viable skin and blood circulation during (bioequivalence) BE assessments.

Detailed description

The clinical study is divided into a pilot and a pivotal study. The pilot study will involve 6 healthy adult participants and in each participant the concentration of lidocaine/prilocaine will be assessed in the dermis and in the systemic circulation after topical application of lidocaine/prilocaine (dermal sampling visit). The pilot study aims to develop the optimal study design for the pivotal study. Thereby the effect of and removal of the topical dose will be tested as well as if this topical dose establishes well quantifiable systemic drug levels that allow an investigation of the cross-talk between skin and systemic circulation within the pivotal study. Further the feasibility of dermal microdialysis (dMD) will be tested and compared with dOFM. The pivotal study will involve 20 healthy adult participants. It aims to investigate a potential cross-talk between skin and systemic circulation by comparing dermal lidocaine/prilocaine concentrations (assessed with dOFM and MD) and blood lidocaine/prilocaine concentrations in a dermal sampling visit. Furthermore, the systemic clearance of lidocaine will be investigated in each of the 20 participants in a separate clearance visit after intravenous infusion of lidocaine. In the dermal sampling visits dOFM and microdialysis probes will be inserted into the dermis to monitor the dermal drug concentration up to 12 h post-dose in topically treated as well as untreated skin sites. Blood samples will be drawn to assess the systemic drug levels. All samples will be assayed for lidocaine and prilocaine concentrations. The blood samples in the clearance visit will be assayed for lidocaine only.

Conditions

• Healthy
• Dermal Pharmacokinetic Measurement

Interventions

Type	Name	Description
PROCEDURE	Intravenous infusion of lidocaine	Lidocaine is intravenously administered in clearance visit and blood samples are taken to calculate individual clearance of each participant.
DRUG	Lidocaine 2.5% and Prilocaine 2.5% cream", USP (2.5% lidocaine, 2.5% prilocaine, Actavis Pharma incorporated, USA)	Topical application in dermal-sampling visit
DRUG	Lidocorit 2%-Ampullen" (Gebro Pharma Gesellschaft mit beschränkter Haftung, Austria)	Intravenous infusion in clearance visit
DEVICE	Dermal open flow microperfusion	Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentration in the dermis. Interstitial fluid (ISF) sampling: 1 hour pre-dose and 12 hours post-dose
DEVICE	Dermal Microdialysis	Dermal microdialysis will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentrations in the dermis. Interstitial fluid (ISF) sampling: 1 hour pre-dose and 12 hours post-dose
PROCEDURE	Blood sampling in dermal sampling visit	1 sample is taken pre-dose and 12 samples are taken post-dose.
PROCEDURE	Blood sampling in clearance visit	1 sample is taken pre-dose, 3 samples during intravenous infusion and 13 samples post-dose.

Timeline

• Start date: 2019-01-16
• Primary completion: 2019-08-28
• Completion: 2019-08-28
• First posted: 2019-01-23
• Last updated: 2023-02-10

Locations

1 site across 1 country: Austria