title: Evaluation of the activity and safety of CS21 barrier genital gel® compared to topical aciclovir and placebo in symptoms of genital herpes recurrences: a randomized clinical trial.
abstract: BACKGROUND
  Topical or systemic antiviral drugs reduce the duration of genital herpes recurrences but may not always alleviate functional symptoms.
  
  
  OBJECTIVE
  To assess the efficacy and safety of oxygenated glycerol triesters-based CS21 barrier genital gel(®) vs. topical aciclovir and placebo (vehicle) in resolving functional symptoms and in healing of genital herpes recurrences.
  
  
  METHODS
  A prospective randomized controlled, investigator-blinded trial of CS21 barrier genital gel(®) vs. topical aciclovir (reference treatment) and placebo (vehicle) was designed. The primary endpoint was the cumulative score of four herpes-related functional symptoms (pain, burning, itching and tingling sensations). Secondary endpoints included objective skin changes (erythema, papules, vesicles, oedema, erosion/ulceration, crusts), time to heal, local tolerance and overall acceptability of the treatment as reported by a self-administered questionnaire.
  
  
  RESULTS
  Overall, 61 patients were included. CS 21 barrier genital gel(®) was significantly more efficient than topical aciclovir and vehicle for subjective symptoms and pain relief in genital herpes recurrences; additionally, time to heal was significantly shorter with CS 21 than with vehicle, whereas no significantly difference was observed between patients receiving topical aciclovir and vehicle. The treatments under investigation were well tolerated and the adverse events were comparable in the three treatment groups.
  
  
  CONCLUSIONS
  Overall, these results support the interest of using of CS 21 barrier genital gel(®) in symptomatic genital herpes recurrences. Accordingly, this product offers a valuable alternative in topical management of recurrent genital herpes.
authors.affiliation: Service de Dermatologie Hôpital L'Archet 2, Nice Cedex 3, France.
authors.forename: A
authors.initials: A
authors.lastname: Khemis
authors.forename: L
authors.initials: L
authors.lastname: Duteil
authors.forename: Y
authors.initials: Y
authors.lastname: Tillet
authors.forename: O
authors.initials: O
authors.lastname: Dereure
authors.forename: J-P
authors.initials: JP
authors.lastname: Ortonne
mesh_terms: D000212:Acyclovir / Q000008:administration & dosage*; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D005260:Female; D005782:Gels; D006558:Herpes Genitalis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D016037:Single-Blind Method; D014280:Triglycerides / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D005782:Gels; D014280:Triglycerides; D000212:Acyclovir