Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis

Phase 3 Completed 1443 enrolled Medivir

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis.

Timeline

Start: 2006-07
Primary completion: 2007-08
Completion: 2007-12

Outcome

Met primary endpoint

paper Of patients receiving ME-609, 42% did not develop an ulcerative lesion compared with 35% of patients receiving acyclovir in ME-609 vehicle (P = .014) PMID 20851499 ↗

Publications

Hull CM, Harmenberg J, Arlander E, Aoki F, Bring J, Darpo B, Levin MJ, Tyring S, Spruance SL; ME-609 Study Group. Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: a randomized, double-blind, placebo-controlled, patient-initiated clinical trial. J Am Acad Dermatol. 2011 Apr;64(4):696.e1-11. doi: 10.1016/j.jaad.2010.08.012. Epub 2010 Sep 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acyclovir	Small molecule	5 %	Topical
Subject	Hydrocortisone	Other / unclassified	1 %	Topical