Valaciclovir as a single dose during prodrome of herpes facialis: a pilot randomized double-blind clinical trial.

Author(s): Chosidow O, Drouault Y, Garraffo R, Veyssier P, Valaciclovir Herpes Facialis Study Group

Affiliation(s): Department of Internal Medicine, Assistance Publique-Hopitaux de Paris, Groupe Hospitalier Pitie-Salpetriere, Universite Paris VI, 47-83 boulevard de l'Hopital, France. olivier.chosidow@psl.ap-hop-paris.fr

Publication date & source: 2003-01, Br J Dermatol., 148(1):142-6.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

BACKGROUND: Randomized clinical trials of valaciclovir in recurrent herpes labialis are lacking. OBJECTIVES: To determine whether a single course of valaciclovir, i.e. 500, 1000 or 2000 mg, administered during the prodrome of herpes facialis, could be beneficial. METHODS: Three hundred and forty-five out-patients with herpes labialis were screened and randomized for a multicentre, double-blind clinical trial. Ninety-six patients had no recurrence after 6 months of follow-up; 249 patients were finally included in the intent-to-treat (ITT) population. The main outcome measure was the rate of aborted episodes at day 3. The three treatment groups were similar at baseline. RESULTS: There was no statistically significant difference between the groups in rates of aborted lesions at day 3 in the ITT population, in particular between the 500 mg and 2000 mg treatment groups. CONCLUSIONS: Although a placebo group was not included in this pilot study, a single dose of valaciclovir was not considered beneficial in patients with recurrent herpes facialis.