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 - 10/08/11
, Johan Harmenberg, MD, PhD b, Eva Arlander, PhD c, Fred Aoki, MD d, Johan Bring, PhD e, Börje Darpö, MD, PhD c, f, Myron J. Levin, MD g, Stephen Tyring, MD, PhD h, Spotswood L. Spruance, MD aME-609 Study Group
Reprint requests: Christopher M. Hull, MD, Department of Dermatology, 4A330 School of Medicine, University of Utah, 30 North 1900 East, Salt Lake City, UT 84132-2409.Abstract |
Background |
Prior pilot studies support the use of antiviral medications with topical corticosteroids for herpes simplex labialis (HSL). ME-609 (Xerese, Xerclear) is a combination of 5% acyclovir and 1% hydrocortisone developed for the topical treatment of HSL.
Objectives |
The primary study end point was the prevention of ulcerative HSL lesions.
Methods |
In all, 2437 patients with a history of HSL were randomized to self-initiate treatment with ME-609, 5% acyclovir in ME-609 vehicle, or ME-609 vehicle (placebo) at the earliest sign of a cold sore recurrence. Cream was applied 5 times/d for 5 days. A total of 1443 patients experienced a recurrence and initiated treatment with ME-609 (n = 601), acyclovir (n = 610), or placebo (n = 232).
Results |
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) and 26% of patients receiving placebo (P < .0001). In patients with ulcerative lesions, healing times were reduced in the ME-609 and acyclovir groups compared with placebo (P < .01 for both). The cumulative lesion area for all lesions was reduced 50% in patients receiving ME-609 compared with the placebo group (P < .0001). There were no differences among groups in the number of patients with positive herpes simplex virus cultures. The side-effect profile was similar among treatments.
Limitations |
The study did not contain a group treated with a topical corticosteroid alone.
Conclusions |
ME-609 prevented progression of cold sores to ulcerative lesions and significantly reduced the cumulative lesion area compared with acyclovir and placebo. ME-609 treatment offers additional therapeutic benefit compared with therapy with topical acyclovir alone.
Le texte complet de cet article est disponible en PDF.Key words : episodic treatment, herpes labialis, herpes simplex virus, prevention, recurrence
Abbreviations used : CI, HSL, HSV, ITT
Plan
| Preparation of this manuscript was supported by Medivir AB. |
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| Disclosure: Dr Hull has been an investigator, speaker, and consultant for GlaxoSmithKline and Novartis. He has been an investigator for Medivir AB. Dr Spruance is a consultant for Medivir AB but was not a study investigator. Dr Harmenberg is a former employee and consultant of Medivir AB, owns stock in Medivir AB, and is one of the inventors of ME-609. Dr Levin has been an investigator for and is a consultant to GlaxoSmithKline, Merck & Co, and Medivir AB. He receives research support from Merck & Co, GlaxoSmithKline, Inhibitex, SanofiPasteur, and Medivir AB. He also serves as a consultant for Astellas Pharmaceuticals and shares a patent with Merck & Co. Dr Darpö has worked as a consultant for Medivir AB. Dr Tyring has been an investigator for Medivir AB. Dr Bring has worked as a consultant for Medivir AB. Dr Arlander is an employee of Medivir AB and has stock options in Medivir AB. Dr Aoki has no conflicts of interest to declare. |
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| ClinicalTrials.gov Registration: NCT00361881 |
Vol 64 - N° 4
P. 696.e1-696.e11 - avril 2011 Retour au numéro
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