Single-dose, patient-initiated famciclovir: a randomized, double-blind, placebo-controlled trial for episodic treatment of herpes labialis

J Am Acad Dermatol. 2006 Jul;55(1):47-53. doi: 10.1016/j.jaad.2006.02.031.


Background: The brief period of viral replication in recurrent herpes labialis lesions suggests shorter therapeutic regimens are a logical episodic treatment strategy.

Objective: We sought to assess the efficacy and safety of single-dose and single-day famciclovir treatments.

Methods: In all, 701 randomly assigned patients self-initiated therapy with famciclovir (1500 mg once [single dose] or 750 mg twice a day for 1 day [single day]) or placebo within 1 hour of onset of the prodromal symptoms of an episode of herpes labialis. Lesion healing was monitored by diaries and frequent clinic visits.

Results: Median healing times of primary (first to appear) vesicular lesions in the famciclovir single-dose, famciclovir single-day, and placebo groups were 4.4, 4.0, and 6.2 days, respectively. There was no significant difference between the famciclovir regimens. Adverse events in the famciclovir groups were similar to placebo.

Limitations: The active arms of this trial were not directly compared to other antiviral regimens.

Conclusion: Single-dose famciclovir reduced time to healing of herpes labialis lesions by approximately 2 days compared with placebo.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Aminopurine / administration & dosage
  • 2-Aminopurine / analogs & derivatives*
  • Administration, Oral
  • Adult
  • Antiviral Agents / administration & dosage*
  • Double-Blind Method
  • Famciclovir
  • Female
  • Herpes Labialis / drug therapy*
  • Humans
  • Male
  • Self Administration
  • Time Factors


  • Antiviral Agents
  • 2-Aminopurine
  • Famciclovir