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 study was to evaluate the specific clinical efficacy and tolerance of human leukocyte interferon-alpha (2 x 10(6) IU/g) and podophyllotoxin 0.5% incorporated in a hydrophilic cream to cure genital warts. Preselected Asian women (n = 60) aged 18-40 years (mean 22.9), with a clinical and biopsy-confirmed diagnosis of genital warts, harboring 322 lesions (mean 5.36) were randomly assigned to three parallel groups to receive one of the two test drugs or placebo. Each patient received a precoded tube (40 g) containing either human leukocyte interferon-alpha, podophyllotoxin, 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 week). Patients were examined on a weekly basis, and a cure was considered to be a biopsy-confirmed, total elimination of a lesion. Moreover, patients cured during the study period were spared further therapy, and were requested to return in 16 weeks to monitor for the occurrence of a relapse. The remaining patients' empty tubes were collected, and similarly precoded replacement tubes were given to continue the treatment; a total of 214 tubes were used. The study was scheduled for 16 weeks with 4 weeks of active treatment. Individuals were excluded from the study due to pregnancy, breast feeding, or the receiving of any type of antiviral therapy during the 4 weeks preceding enrollment.(ABSTRACT TRUNCATED AT 250 WORDS)

Human leukocyte interferon-alpha in cream for the management of genital herpes in Asian women: a placebo-controlled, double-blind study.

This double-blind, placebo-controlled study examined the clinical efficacy and tolerance of human leukocyte interferon-alpha (2 x 10(6) IU/g) in hydrophilic cream to cure patients afflicted with first episodes of genital herpes. Sixty patients aged 18-40 years (mean 24.5) with culture-confirmed herpes simplex genitalis, bearing 755 lesions (mean 12.6) were randomized to active and placebo groups. Patients joined the study within 7 days (mean 4.1) of the manifestation of lesions. Each patient was given a precoded 40-g tube containing placebo/active preparation with instructions on self-application of the trial medication to their lesions three times daily for 5 consecutive days (max. 15 topical applications per week). Patients were examined three times a week to evaluate clinical efficacy and other beneficial effects. A reepithelialized lesion with some residual erythema was recorded as healed. Patients resolved during the active treatment period (1-4 weeks) were spared further therapy and were requested to visit us as scheduled for posttreatment control after 16 weeks. From the remaining patients empty tubes were collected, and similarly coded replacement tubes were given to continue the treatment (in total 160 tubes were used). Patients treated with leukocyte interferon-alpha cream had significantly shorter mean duration of viral shedding/healing than placebo recipients, (6.2 days vs. 15 days; P < 0.01); thus the number of healed patients was 25/30 (83.3%) vs. 5/30 (17%; P < 0.001. Of the 60 patients 49 (81.6%) complained no drug-related side effects.(ABSTRACT TRUNCATED AT 250 WORDS)

Human leukocyte interferon-alpha in cream for the treatment of genital herpes in Asian males. A placebo-controlled, double-blind study.

BACKGROUND: Genital herpes simplex virus infection, a sexually transmitted disease, is the commonest cause of ulcerative genital infections among the young and adult population. The recurrent nature of the disease, possible cause of cervical dysplasia and neonatal herpes are the primary concern associated with this infection. OBJECTIVE: The purpose of this double-blind, placebo-controlled study was to evaluate the clinical efficacy and tolerance of human leukocyte inferon-alpha in hydrophilic cream (2x10(6)IU/g) to cure patients afflicted with first episodes of genital herpes. METHODS: Patients (n = 60), aged 18-40 years (mean: 22.8) with culture-confirmed diagnosis of herpes simplex genitalis, harboring 751 lesions (mean: 12.5) were randomly allocated to two parallel groups (active/placebo). Patients entered the study within 7 days (mean:4.2) of the onset of lesions. Each patient received a precoded 40-gram tube with instructions to apply the trial medication (at home) on their lesions thrice daily for 5 consecutive days (max. 15 topical applications/week). To assess the clinical efficacy patients were examined twice a week. A completely reepithelized lesion with persistent erythema was evaluated as healed or cured. Patients cured during the subsequent treatment period were spared further therapy and were requested to visit us as scheduled for recurrence control. As for the remaining patients, the same course was continued further (max. 4 weeks active treatment). The study was scheduled for 16 weeks, with 20 months of follow-up (on a monthly basis). RESULTS: The treatment was well tolerated by all the patients. Patients treated with leukocyte interferon-alpha cream had a significantly shorter mean duration of healing than placebo recipients, 5.9 versus 15 days (p < 0.01), as well as the number of cured patients, 24/30 (80%) versus 5/30 (17%; p < 0.001), with mild and nonobjective complaints of drug-related adverse symptoms; there were no dropouts. Five of the cured patients (5/29, 17%) showed recurrence after 22 months. CONCLUSIONS: The results substantiate that human leukocyte interferon-alpha (2 x 10(6) IU/g) in hydrophilic cream is more efficacious than placebo and testify that the regimen can be considered a home-based reliable treatment to cure first episodes of genital herpes in males.