An Exploratory Study to Evaluate Dermal Open Flow Microperfusion's (dOFM) Ability to Assess Bioequivalence and Non-bioequivalence of Topical Acyclovir Formulations in Healthy Volunteers (FDA_BE1)

NCT02711267 NA COMPLETED

The overall aim of this clinical study is to investigate the ability of dermal open flow microperfusion to assess bioequivalence and non-bioequivalence of acyclovir formulations in the skin of healthy volunteers.

Details

Lead sponsor	Medical University of Graz
Phase	NA
Status	COMPLETED
Enrolment	36
Start date	2014-01
Completion	2015-08

Conditions

• Dermatologic Disorders

Interventions

• 5% Zovirax® cream
• 5% Aciclostad cream
• 5% Aciclovir cream 1A Pharma
• 5% Zovirax Cold Sore Cream
• 5% Zovirax® cream (Austria)
• OFM
• OFM Probe
• OFM Pump

Primary outcomes

• AUC — during 12-36h of OFM-Sampling (post-dose)
  Area under the dOFM acyclovir concentration curve (AUC) during 12/36h of OFM-Sampling (post-dose)
• CMAX — during 12-36h of OFM-Sampling (post-dose)
  Maximum observed dOFM acyclovir concentration (CMAX) during 12/36h of OFM-Sampling (post-dose)

Countries

Austria