Valaciclovir as a single dose during prodrome of herpes facialis: a pilot randomized double-blind clinical trial.
BACKGROUND
Randomized clinical trials of valaciclovir in recurrent herpes labialis are lacking.


OBJECTIVE
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.
Chosidow
O
O
Department of Internal Medicine, Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière, Université Paris VI, 47-83 boulevard de l'Hôpital, France. olivier.chosidow@psl.ap-hop-paris.fr
Drouault
Y
Y
Garraffo
R
R
Veyssier
P
P
D000212:Acyclovir / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006560:Herpes Labialis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011355:Prodrugs / Q000627:therapeutic use*; D012008:Recurrence; D016896:Treatment Outcome; D000077483:Valacyclovir; D014633:Valine / Q000031:analogs & derivatives* / Q000627:therapeutic use*
D000998:Antiviral Agents; D011355:Prodrugs; D014633:Valine; D000077483:Valacyclovir; D000212:Acyclovir