Safety and efficacy of 0.5% podofilox gel in the treatment of anogenital warts.
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.
Tyring
S
S
Department of Dermatology and Microbiology, University of Texas Medical Branch, Galveston 77555, USA.
Edwards
L
L
Cherry
L K
LK
Ramsdell
W M
WM
Kotner
S
S
Greenberg
M D
MD
Vance
J C
JC
Barnum
G
G
Dromgoole
S H
SH
Killey
F P
FP
Toter
T
T
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
D005782:Gels; D007641:Keratolytic Agents; D014677:Pharmaceutical Vehicles; D011034:Podophyllotoxin