HUMAN-LEUKOCYTE INTERFERON-ALPHA VERSUS PODOPHYLLOTOXIN IN CREAM FOR THE TREATMENT OF GENITAL WARTS IN MALES - A PLACEBO-CONTROLLED, DOUBLE-BLIND, COMPARATIVE-STUDY

Background: The incidence of overt genital warts, a common sexually tr ansmitted disease of high prevalence, has been on the rise for the las t few years. The infection is caused by several types of human papillo maviruses (HPVs), some of which have been accepted as a factor in the pathogenesis of genital squamous-cell carcinomas. Objective: The aim o f this double-blind, placebo-controlled study was to compare and evide nce differences in clinical efficacy and tolerance between human leuko cyte interferon-alpha (2x10(6) IU/g) and podophyllotoxin (0.5%), incor porated in a hydrophilic cream base to cure genital warts in Asian mal es. Methods: Sixty patients, circumcised, who ranged in age from 18 to 40 years (mean 25.0), diagnosed with the evidence of penoscopy and HP V DNA (Southern dot blot) as harboring 396 lesions (mean 6.6), were ra ndomized to three parallel groups. Each subject was allocated a preced ed tube (40 g) containing one of two trial preparations or matching pl acebo for 3 days' (consecutive) usage, thrice daily. The study lasted 16 weeks with 4 weeks of active treatment. The patients were examined on a weekly basis, and a clinically and HPV-DNA-confirmed total regres sion of lesions was recorded as cured. Patients cured during the treat ment were spared further therapy and were requested to visit us as sch eduled for poststudy follow-up. Results: Findings indicated that patie nts treated with leukocyte interferon-alpha cream had shown comparativ ely better results than the podophyllotoxin-treated group (90 vs. 55%, p < 0.0285) or the placebo group (15%). Mild and transient localized erythema (8.3%), burning sensation (6.6%) and transitory increase in b ody temperature (> 38 degrees C; 6.6%) were the most frequent adverse symptoms with no dropout. The study was followed up for 1 year, and ou t of 32/60 (53.3%) cured patients 3 had a relapse after 10 months. Con clusion: Leukocyte interferon-alpha (2x10(6) IU/g) has shown comparati vely better results than 0.5% podophyllotoxin and placebo in a hydroph ilic cream base, thus leukocyte interferon-alpha in cream may provide an alternative and effective regimen to treat genital warts in males.