The overall aim of this clinical study is to develop a general bioequivalence (BE) testing method using dermal open flow microperfusion (dOFM) for dermatological drug products. In this study BE of different lidocaine/prilocaine products will be assessed and factors that influence dOFM data variability will be evaluated.
The study will involve 20 healthy adult participants. Dermal pharmacokinetic (PK) profile of three different lidocaine/prilocaine products will be assessed in parallel at different skin sites on the same participant. For BE evaluations a reference product will be compared against itself and an approved generic test product as positive control and against a non-equivalent test product as negative control. Additionally different non-invasive measurements (e.g. TEWL) will be conducted and results will be correlated with lidocaine/prilocaine PK data to identify factors that might influence skin penetration. dOFM probes will be inserted into the dermis to monitor the dermal drug concentrations up to 12 h post-dose in topically treated skin sites. Blood samples will be drawn to rule out systemic appearance of lidocaine and/or prilocaine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Topical application
Topical application
Topical application
Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentration in the dermis. 16 dOFM probes will be implanted per participant (8 test-sites; 2 dOFM probes per test-site). From each dOFM probe 13 samples will be taken (1 pre-dose, 12 post-dose).
1 sample will be taken pre-dose and 12 samples post-dose.
CTU - Clinical Trials Unit, Medical University Graz
Graz, Austria
Area under the dermal concentration versus time curve for lidocaine
Dermal concentrations (ng/mL) of lidocaine will be measured to calculate the area under the dermal concentration versus time curve AUC (ng\*h/mL).
Time frame: 13 hours
Area under the dermal concentration versus time curve for prilocaine
Dermal concentrations (ng/mL) of prilocaine will be measured to calculate the area under the dermal concentration versus time curve AUC (ng\*h/mL).
Time frame: 13 hours
Maximal dermal concentration of lidocaine
Dermal concentrations (ng/mL) of lidocaine will be measured to calculate the maximal dermal concentration (ng/mL).
Time frame: 13 hours
Maximal dermal concentration of prilocaine
Dermal concentrations (ng/mL) of prilocaine will be measured to calculate the maximal dermal concentration (ng/mL).
Time frame: 13 hours
Blood lidocaine concentrations versus time curve
Lidocaine concentrations (ng/mL) in the blood will be measured to obtain the concentration-time curves in the blood.
Time frame: 13 hours
Blood prilocaine concentrations versus time curve
Prilocaine concentrations (ng/mL) in the blood will be measured to obtain the concentration-time curves in the blood.
Time frame: 13 hours
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