title: Recombinant interferon beta gel as an adjuvant in the treatment of recurrent genital warts: results of a placebo-controlled double-blind study in 120 patients.
abstract: BACKGROUND
  Pilot studies of adjuvant therapy with topically applied interferons (IFN) have shown promising results in reducing the recurrence of condylomata acuminata (CA).
  
  
  OBJECTIVE
  The aim of this multicenter placebo-controlled, double-blind study was to confirm the efficacy and safety of topically applied IFN in a large sample of patients.
  
  
  METHODS
  After removal of CA by CO2 laser surgery, electrocautery or cryosurgery, 120 patients applied either recombinant IFN-beta (0.15 or 1.0 x 10(6) IU/g) or placebo gel to the affected areas 5 times daily for 4 weeks. The patients were followed for a total of 24 weeks or until recurrence of CA was observed, respectively.
  
  
  RESULTS
  In the 105 patients evaluated for efficacy after 24 weeks, recurrence rates were 75% (27/36 patients) in the placebo group, 62% (21/34) in the 1.0 x 10(6) IU/g group (n.s.) and 54% (19/35) in the 0.15 x 10(6) IU/g group (p = 0.034). Only few mild adverse events were noted, which were almost limited to the application site.
  
  
  CONCLUSIONS
  Topical application of gel containing 0.15 x 10(6) IU/g recombinant IFN-beta is safe and appears to reduce the recurrence of CA after surgical treatment.
authors.affiliation: Department of Dermatology, University of Hamburg, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Gross
authors.forename: T
authors.initials: T
authors.lastname: Rogozinski
authors.forename: H
authors.initials: H
authors.lastname: Schöfer
authors.forename: S
authors.initials: S
authors.lastname: Jabłońska
authors.forename: A
authors.initials: A
authors.lastname: Roussaki
authors.forename: C
authors.initials: C
authors.lastname: Wöhr
authors.forename: J
authors.initials: J
authors.lastname: Brzoska
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003218:Condylomata Acuminata / Q000188:drug therapy* / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016899:Interferon-beta / Q000627:therapeutic use*; D008297:Male; D010865:Pilot Projects; D011994:Recombinant Proteins / Q000627:therapeutic use; D012008:Recurrence; D012871:Skin Diseases / Q000188:drug therapy* / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D011994:Recombinant Proteins; D016899:Interferon-beta