MANAGEMENT OF GENITAL WARTS IN WOMEN WITH HUMAN-LEUKOCYTE INTERFERON-ALPHA VS PODOPHYLLOTOXIN IN CREAM - A PLACEBO-CONTROLLED, DOUBLE-BLIND, COMPARATIVE-STUDY

The purpose of this double-blind, placebo-controlled, comparative stud y was to evaluate the specific clinical efficacy and tolerance of huma n leukocyte interferon-alpha (2x10(6) IU/g) and podophyllotoxin 0.5% i ncorporated in a hydrophilic cream to cure genital warts. Preselected Asian women (n=60) aged 18-40 years (mean 22.9), with a clinical and b iopsy-confirmed diagnosis of genital warts, harboring 322 lesions (mea n 5.36) were randomly assigned to three parallel groups to receive one of the two test drugs or placebo. Each patient received a preceded tu be (40 g) containing either human leukocyte interferon-alpha, podophyl lotoxin, or identically appearing placebo cream for 3 days' usage. In addition to written instructions, each subject was shown how to apply a minimal amount of trial medication on their lesions thrice daily for 3 consecutive days per week (maximum nine topical applications per we ek). Patients were examined on a weekly basis, and a cure was consider ed to be a biopsy-confirmed, total elimination of a lesion. Moreover, patients cured during the study period were spared further therapy, an d were requested to return in 16 weeks to monitor for the occurrence o f a relapse. The remaining patients' empty tubes were collected, and s imilarly preceded replacement tubes were given to continue the treatme nt; a total of 214 tubes were used. The study was scheduled for 16 wee ks with 4 weeks of active treatment. Individuals were excluded from th e study due to pregnancy, breast feeding, or the receiving of any type of antiviral therapy during the 4 weeks preceding enrollment. Better results were obtained with leukocyte interferon-alpha cream than with podophyllotoxin both in terms of the number of cured patients (18/20 v s. 12/20, or 90% vs. 60%; P<0.0285) and the number of eliminated lesio ns (105/110 vs. 87/108, or 95.5% vs. 80.5%; P<0.001. In the placebo gr oup 4/20 (20%) patients were cured, indicating lower results. Out of t he 60 patients 51 (85%) complained of no drug-related symptomatic side effects. However, the most frequent nonobjective adverse symptoms exp erienced by the patients were mild tenderness 4/60 (6.6%), burning sen sation 3/60 (5%), and transitory increase in body temperature (>38 deg rees C) accompanied by headache and itching 2/60 (3.3%). None of the p atients suffering from these side effects elected to discontinue the s tudy. The patients were evaluated for 1 year after the initial visit, and among the 34/60 (56.6%) cured patients two had a relapse after 9 m onths. In conclusion, the clinical results of this study demonstrate t hat leukocyte inter feron-alpha (2x10(6) IU/g) is more efficacious tha n 0.5% podophyllotoxin and placebo in hydrophilic cream, and substanti ates that along with mild, nonobjective, transient, localized, adverse symptoms, human leukocyte alpha-interferon therapy is more effective and better than podophyllotoxin in cream for curing genital warts in w omen