NCT01257074

Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis

A Randomized, Double-Blind, to Compare Non-inferiority Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Herpes labialis is the most common recurrent manifestation of herpes simplex. The purpose of this study is to check the non-inferiority efficacy and safety of penciclovir 10mg/g as treatment for Herpes Labialis in comparison to acyclovir 50mg/g.

Detailed description

Study design: • Double blinded non-inferiority prospective parallel-group, intend to treat trial. Study design: * Experiment duration: 10 days * 3 visits (days 1,5 and 10) * Erythema, papule, vesicle, ulcer, crust and healed skin evaluation * Adverse events evaluation

Conditions

• Herpes Labialis

Interventions

Type	Name	Description
DRUG	Acyclovir 50mg/g	Cream, dose 5 times daily during 5 days
DRUG	Penciclovir 10mg/g	Cream, dose 5 times daily during 5 days

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-03-01
• Completion: 2012-10-01
• First posted: 2010-12-09
• Last updated: 2013-03-04

Locations

1 site across 1 country: Brazil