A randomized, double-blind, placebo-controlled study to test the efficacy of topical 2-hydroxypropyl-Beta-cyclodextrin in the prophylaxis of recurrent herpes labialis

Dermatology. 2013;226(3):247-52. doi: 10.1159/000349991. Epub 2013 Jun 25.

Abstract

Herpes labialis affects one third of the population. We evaluated the topical application of an antiviral compound, hydroxypropyl-β-cyclodextrin (2-HPβCD), in reducing herpes labialis relapses. In this double-blind, randomized, placebo-controlled trial, 40 patients were randomized to a polyethylene glycol (PEG) formulation containing 20% 2-HPβCD or to a vehicle control arm. The gel was applied to the lips twice daily for 6 months. The primary objective was reducing herpes relapses. Surprisingly, the drug group had significantly more relapses than the vehicle group (p = 0.003). While the median numbers of relapses in the preceding year were 12 in the vehicle group and 10 in the drug group, both groups experienced very few relapses during the 6-month treatment period, with a median of 0 in the vehicle group and a median of 2 in the drug group. The impressive reduction of relapses in both groups may be due to a placebo effect or due to the topical treatment with PEG.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • 2-Hydroxypropyl-beta-cyclodextrin
  • Acyclovir / therapeutic use
  • Administration, Topical
  • Adult
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / therapeutic use*
  • Double-Blind Method
  • Female
  • Gels / therapeutic use
  • Herpes Labialis / prevention & control*
  • Humans
  • Middle Aged
  • Pharmaceutical Vehicles / therapeutic use
  • Polyethylene Glycols / therapeutic use
  • Secondary Prevention
  • Young Adult
  • beta-Cyclodextrins / administration & dosage
  • beta-Cyclodextrins / therapeutic use*

Substances

  • Antiviral Agents
  • Gels
  • Pharmaceutical Vehicles
  • beta-Cyclodextrins
  • 2-Hydroxypropyl-beta-cyclodextrin
  • Polyethylene Glycols
  • Acyclovir