NCT00735761

Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients

A Randomized, Double-Blind, Active-Controlled, Subject Initiated Study Comparing ME-609 to Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis in Immunocompromised Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Medivir · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the episode duration of a herpes labialis recurrence in immunocompromised patients treated with ME-609 or Acyclovir.

Detailed description

The objective of this study was to evaluate the episode duration of a herpes labialis recurrence, following a 5-day treatment with 5-time daily topical administration of ME-609 or acyclovir cream, in immunocompromised adults, 18 years and older. This interim report summarizes the results for short-term observations, i.e., during the initial study recurrence. A final study report will be prepared when the long-term follow-up is completed.

Conditions

• Herpes Labialis

Interventions

Type	Name	Description
DRUG	ME-609	Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application
DRUG	Acyclovir in ME-609 vehicle (5% acyclovir)	Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2008-08-15
• Last updated: 2008-08-15