title: Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial.
abstract: BACKGROUND
  Treatment of herpes simplex labialis (HSL) has been associated with modest benefits. This difficulty results from the rapid resolution of the disease accomplished by the immune system, which narrows the window of therapeutic opportunity. The immune response is also responsible for important clinical manifestations, including oedema and pain. The dual role of immune responses (protection, pathology) is well recognized in other infectious diseases. The addition of corticosteroids to antimicrobial agents has been associated with improvement in some of these diseases.
  
  
  OBJECTIVE
  We evaluated the combination of oral valacyclovir plus topical clobetasol compared to placebo for recurrent HSL.
  
  
  METHODS
  Eighty-one subjects were screened, randomized, and dispensed medication (valacyclovir 2 g orally twice daily phiomicronrho 1 day and clobetasol gel 0.05% twice daily for 3 days). Forty-two patients developed a recurrence and initiated treatment.
  
  
  RESULTS
  There were more aborted lesions in the valacyclovir-clobetasol arm compared to placebo-placebo (50% vs.15.8%, P = 0.04). Combination therapy reduced the mean maximum lesion size (9.7 vs. 54 mm(2), P = 0.002) and the mean healing time of classical lesions (5.8 vs. 9.3 days, P = 0.002). We created a composite statistic, area-under-the-curve (AUC) of classical lesion size versus time. There was a reduction in the AUC in the combination arm compared with placebo (23 vs. 193 mm(2), P < 0.001). Adverse events were minimal. Secondary and post-treatment recurrences were not increased by combination therapy.
  
  
  CONCLUSIONS
  This pilot study supports the addition of topical corticosteroids to an oral antiviral agent for the treatment of HSL. Larger studies need to confirm the safety and efficacy of this approach.
authors.affiliation: Department of Dermatology, University of Utah, Salt Lake City, UT, USA. christopher.hull@hsc.utah.edu
authors.forename: C
authors.initials: C
authors.lastname: Hull
authors.forename: M
authors.initials: M
authors.lastname: McKeough
authors.forename: K
authors.initials: K
authors.lastname: Sebastian
authors.forename: J
authors.initials: J
authors.lastname: Kriesel
authors.forename: S
authors.initials: S
authors.lastname: Spruance
mesh_terms: D000212:Acyclovir / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000284:Administration, Oral; D000287:Administration, Topical; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019540:Area Under Curve; D002990:Clobetasol / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005782:Gels; D006560:Herpes Labialis / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D008297:Male; D010865:Pilot Projects; D010919:Placebos; D000077483:Valacyclovir; D014633:Valine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000893:Anti-Inflammatory Agents; D000998:Antiviral Agents; D005782:Gels; D010919:Placebos; D002990:Clobetasol; D014633:Valine; D000077483:Valacyclovir; D000212:Acyclovir