HUMAN-LEUKOCYTE INTERFERON-ALPHA IN CREAM, FOR THE TREATMENT OF GENITAL WARTS IN ASIAN WOMEN - A PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY

The purpose of this double-blind, placebo-controlled study was to dete rmine and compare the clinical efficacy and tolerance of human leukocy te alpha-interferon (incorporated 2 x 10(6) IU/g) in hydrophilic cream to cure genital warts. Preselected Asian female patients (n = 150) ag ed 18-40 years (mean 22.5), with the clinical and biopsy-confirmed dia gnosis of genital warts (mean 2.64), predominantly flat vaginal condyl omas, were randomly allocated to 3 parallel groups. Each patient was g iven a coded tube containing 80 g placebo/active preparation with a gr aduated applicator. Patients were instructed to inject 6 g of the eith er alloted placebo/active cream deep into the vagina thrice a day for 3 consecutive days (group A) or 4 consecutive days (group B) per week, and if not cured the same treatment was extended to 3 more weeks (max imum 4 weeks active treatment). To assess the clinical efficacy patien ts were examined on a week-to-week basis. A total clearance of warts ( biopsy-confirmed) was evaluated as a complete cure. Patients cured dur ing the treatment were spared further treatment and were requested to visit us after 16 weeks for relapse control. As for the remaining pati ents, empty tubes were collected, and similarly coded replacement tube s were given for further treatment (in total 588 tubes were used). By the end of the treatment 57.2% lesions (227/397) were eliminated in al l the groups: 48% patients in group A, 90% patients in group B, and 10 % patients in placebo groups taken as completely cured. Of the 150 pat ients 128 (85.3%) did not complain of any drug-related adverse symptom s. Transitory increase in body temperature (mean 38.4 degrees C), acco mpanied by headache (14.6%) and generalized itching (6.6%) were the mo st frequently reported side effects; however, treatment was well toler ated by all the patients, and there were no dropouts. Our findings ind icate that clinical efficacy is dose dependent, that is, the results o f group B were significantly superior to that of group A (P < 0.05). O f the 49.3% cured patients (74/150) followed up for 6 months (monthly basis) seven had a relapse, and none had reinfection. It is concluded that clinical efficacy of leukocyte interferon-alpha to cure genital w arts is dose dependent. These results further support the view that le ukocyte interferon-alpha incorporated in hydrophilic cream can be cons idered a reliable, safe, and home-based treatment to cure vulvar and v aginal warts.