title: Safety and efficacy of 0.5% podofilox gel in the treatment of anogenital warts.
abstract: OBJECTIVE
  To determine the safety and efficacy of a new gel formulation of podofilox in the treatment of anogenital warts.
  
  
  METHODS
  Double-blind, randomized, multicenter, vehicle-controlled investigation.
  
  
  METHODS
  Private dermatology practices, university clinics (dermatology, gynecology, and infectious diseases), and contract research organizations.
  
  
  METHODS
  Three hundred twenty-six patients with anogenital warts.
  
  
  METHODS
  Number of patients with clearing of all treated warts (treatment success).
  
  
  RESULTS
  The 0.5% podofilox gel was significantly better than vehicle gel for successfully eliminating and reducing the number and size of anogenital warts. In the intent-to-treat population, 62 (37.1%) of 167 patients treated with 0.5% podofilox gel had complete clearing of the treated areas (treatment successes) compared with 2 (2.3%) of 86 patients who had clearing of warts with the vehicle gel (P < .001) after 4 weeks. Nineteen additional patients treated with 0.5% podofilox gel and 2 patients treated with vehicle gel had clearing of warts with continued treatment up to 8 weeks. After 8 weeks, 35.9% of the baseline anogenital warts treated with 0.5% podofilox gel remained; this was significantly fewer than in the vehicle-treated group (88.4% of the baseline number) (P = .001). The 0.5% podofilox gel was generally well tolerated, with predominantly mild or moderate local adverse reactions occurring in the majority of patients. Only 7 patients (3.2%), all receiving 0.5% podofilox gel, discontinued study treatment because of drug-related local reactions.
  
  
  CONCLUSIONS
  The results demonstrated that 0.5% podofilox gel is safe and significantly more effective than vehicle gel in the treatment of anogenital warts.
authors.affiliation: Department of Dermatology and Microbiology, University of Texas Medical Branch, Galveston 77555, USA.
authors.forename: S
authors.initials: S
authors.lastname: Tyring
authors.forename: L
authors.initials: L
authors.lastname: Edwards
authors.forename: L K
authors.initials: LK
authors.lastname: Cherry
authors.forename: W M
authors.initials: WM
authors.lastname: Ramsdell
authors.forename: S
authors.initials: S
authors.lastname: Kotner
authors.forename: M D
authors.initials: MD
authors.lastname: Greenberg
authors.forename: J C
authors.initials: JC
authors.lastname: Vance
authors.forename: G
authors.initials: G
authors.lastname: Barnum
authors.forename: S H
authors.initials: SH
authors.lastname: Dromgoole
authors.forename: F P
authors.initials: FP
authors.lastname: Killey
authors.forename: T
authors.initials: T
authors.lastname: Toter
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D001004:Anus Diseases / Q000188:drug therapy*; D003218:Condylomata Acuminata / Q000188:drug therapy*; D004311:Double-Blind Method; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D005782:Gels; D005831:Genital Diseases, Female / Q000188:drug therapy*; D005832:Genital Diseases, Male / Q000188:drug therapy*; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007641:Keratolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D014677:Pharmaceutical Vehicles; D011034:Podophyllotoxin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011537:Pruritus / Q000139:chemically induced; D012449:Safety; D012678:Sensation Disorders / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D005782:Gels; D007641:Keratolytic Agents; D014677:Pharmaceutical Vehicles; D011034:Podophyllotoxin