Bioequivalence of Topical Acyclovir in Healthy Volunteers — FDA_BE1  

Dermatologic Disorders Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dermatologic Disorders
• Skin Diseases

• NCT number: NCT02711267
• Study type: Interventional
• Source: Medical University of Graz
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: August 2015