title: Evaluation of the efficacy and safety of a CS20® protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial.
abstract: BACKGROUND
  Topical or systemic antiviral drugs reduce the duration of herpes simplex virus 1 (HSV-1) recurrences but may not alleviate functional symptoms.
  
  
  OBJECTIVE
  To assess the efficacy and safety of CS20 (Acura 24(®) ) protective barrier gel versus topical aciclovir and placebo in resolving functional symptoms in HSV-1 labial recurrences.
  
  
  METHODS
  A prospective, randomized, single-centre, assessor-blinded study of CS20 versus topical aciclovir or placebo. The primary endpoint was the total score of four herpes-related functional symptoms (pain, burning, itching, and tingling sensations), evaluated by visual analogue scale (VAS). Secondary endpoints encompassed objective skin changes (oedema, crusting and erythema), evaluated by specific clinical scores.
  
  
  RESULTS
  In a study of 106 patients, compared with placebo, a significant improvement in total functional symptom score was observed after 1 day of treatment in the CS20 group, but only after 7 days of treatment in the topical aciclovir group. Burning sensations were significantly reduced by CS20 compared with aciclovir (Days 1-2) or placebo (Days 1-7). Compared to placebo, CS20 significantly reduced pain intensity on Days 1-6. CS20 induced significant and early improvements in the clinical scores for oedema and crusting compared with placebo. Time to cure was similar for CS20 and aciclovir. The treatments were well tolerated and adverse events were comparable in the three treatment groups. Limitations  The single-centre and single-blind design of the study and the preselection of patients.
  
  
  CONCLUSIONS
  CS20 showed superior effectiveness against functional symptoms (pain and burning) associated with HSV-1 labial recurrences and was similar to aciclovir for time to cure.
authors: Service de Dermatologie, Hôpital L'Archet 2, 151, route de Saint Antoine de Ginestière, 06202 Nice Cedex 3, France.
authors: A
authors: A
authors: Khemis
authors: L
authors: L
authors: Duteil
authors: A C
authors: AC
authors: Coudert
authors: Y
authors: Y
authors: Tillet
authors: O
authors: O
authors: Dereure
authors: J P
authors: JP
authors: Ortonne
mesh_terms: D000212:Acyclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005782:Gels; D006560:Herpes Labialis / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011446:Prospective Studies; D012008:Recurrence
chemical_list: D000998:Antiviral Agents; D005782:Gels; D010919:Placebos; D000212:Acyclovir