title: Efficacy and safety of aciclovir mucoadhesive buccal tablet in immunocompetent patients with labial herpes (LIP Trial): a double-blind, placebo-controlled, self-initiated trial.
abstract: BACKGROUND
  Single-day, high-dose systemic antiviral drugs are effective in the treatment of labial herpes (herpes labialis [HL]). Aciclovir Lauriad® mucoadhesive buccal tablet (ABT) is an innovative drug delivery system providing high and prolonged exposure to aciclovir in the oral cavity, supporting its evaluation as a single low dose in HL.
  
  
  METHODS
  In this multicenter double-blind placebo-controlled patient-initiated trial, 775 patients with recurrent HL were randomly assigned to either a single application of ABT 50 mg or a matching placebo as soon as prodromal symptoms occurred. The primary endpoint was the time to healing (TTH) of primary vesicular lesion (modified intention-to-treat population). Other endpoints included incidence of blocked episodes, duration of herpes episodes, and incidence and time to next recurrence evaluated during a 9-month follow-up period (intention-to-treat population).
  
  
  RESULTS
  With ABT 50 mg, median TTH of primary vesicular lesion was reduced (7 days vs 7.3 days, P=.015), the incidence of blocked herpes episodes was increased by 24.2% (34.9% vs 28.1%; P=.042), and the median duration of herpes episodes was reduced (5.6 days vs 6.4 days, P=.003). During the 9-month follow-up period, recurrence of herpes lesions was less frequent (64.2% vs 73.6%; P=.027) and delayed (205 days vs 165 days, P=.041) in the ABT 50 mg. Both treatments were safe.
  
  
  CONCLUSIONS
  A single application of ABT improves all endpoints of HL and might modify its clinical course in decreasing the incidence and delaying the onset of the next recurrence.
authors.forename: Thomas
authors.initials: T
authors.lastname: Bieber
authors.forename: Olivier
authors.initials: O
authors.lastname: Chosidow
authors.forename: Neil
authors.initials: N
authors.lastname: Bodsworth
authors.forename: Stephen
authors.initials: S
authors.lastname: Tyring
authors.forename: Jana
authors.initials: J
authors.lastname: Hercogova
authors.forename: Mark
authors.initials: M
authors.lastname: Bloch
authors.forename: Matthew
authors.initials: M
authors.lastname: Davis
authors.forename: Michael
authors.initials: M
authors.lastname: Lewis
authors.forename: David
authors.initials: D
authors.lastname: Boutolleau
authors.forename: Pierre
authors.initials: P
authors.lastname: Attali
mesh_terms: D000212:Acyclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000268:Adhesiveness; D000278:Administration, Buccal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006560:Herpes Labialis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D013607:Tablets; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D013607:Tablets; D000212:Acyclovir