Safety and efficacy of 0.5% podofilox gel in the treatment of anogenital warts

Arch Dermatol. 1998 Jan;134(1):33-8. doi: 10.1001/archderm.134.1.33.


Objective: To determine the safety and efficacy of a new gel formulation of podofilox in the treatment of anogenital warts.

Design: Double-blind, randomized, multicenter, vehicle-controlled investigation.

Setting: Private dermatology practices, university clinics (dermatology, gynecology, and infectious diseases), and contract research organizations.

Patients: Three hundred twenty-six patients with anogenital warts.

Main outcome measure: 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Anus Diseases / drug therapy*
  • Condylomata Acuminata / drug therapy*
  • Double-Blind Method
  • Drug Eruptions / etiology
  • Female
  • Gels
  • Genital Diseases, Female / drug therapy*
  • Genital Diseases, Male / drug therapy*
  • Headache / chemically induced
  • Humans
  • Keratolytic Agents / administration & dosage
  • Keratolytic Agents / adverse effects
  • Keratolytic Agents / therapeutic use*
  • Male
  • Pharmaceutical Vehicles
  • Podophyllotoxin / administration & dosage
  • Podophyllotoxin / adverse effects
  • Podophyllotoxin / therapeutic use*
  • Pruritus / chemically induced
  • Safety
  • Sensation Disorders / chemically induced
  • Treatment Outcome


  • Gels
  • Keratolytic Agents
  • Pharmaceutical Vehicles
  • Podophyllotoxin