NCT02711267

Bioequivalence of Topical Acyclovir in Healthy Volunteers

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This will be a single center, open label, exploratory research study to evaluate the BE of already marketed formulations of acyclovir in dermal interstitial fluid (ISF) in healthy volunteers using dOFM. The study will be conducted at the Clinical Research Center at the Medical University Graz. dOFM represents the most reliable way to sample interstitial fluid from skin, since it provides diluted but otherwise unchanged dermal interstitial fluid. To assess BE and non-BE, we have designed the experiments in such a way that each subject can serve as its own control. Each subject will have two sets of BE and non-BE pairs in parallel. This study is designed to test dOFM, a new sampling method that allows measurement of skin penetration. Measurement of skin penetration enables the reduction of the impact of inter-subject variability and therefore decreases the number of subjects needed to achieve statistical significance.

Conditions

• Dermatologic Disorders

Interventions

Type	Name	Description
DRUG	5% Zovirax® cream	(manufactured by GlaxoSmithKline Pharma in Canada, distributed in the USA by Valeant Pharmaceuticals North America LCC, Bridgewater,NJ 08807)
DRUG	5% Aciclostad cream	(STADA Arzneimittel GmbH, Vienna, Austria)
DRUG	5% Aciclovir cream 1A Pharma	(1A Pharma GmbH, Vienna, Austria)
DRUG	5% Zovirax Cold Sore Cream	(GlaxoSmithKline Consumer Health Care, Brendfort, UK; Marketing authorization holder: Beeham Group PLC, Brendfort, UK)
DRUG	5% Zovirax® cream (Austria)	(GlaxoSmithKline Pharma GmbH, Vienna, Austria)
PROCEDURE	OFM	Sampling method for interstitial fluid
DEVICE	OFM Probe	Sampling probe used during OFM
DEVICE	OFM Pump	Pump used to operate OFM probes

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2016-03-17
• Last updated: 2016-03-17

Locations

1 site across 1 country: Austria