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 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 transmitted disease of high prevalence, has been on the rise for the last few years. The infection is caused by several types of human papillomaviruses (HPVs), some of which have been accepted as a factor in the pathogenesis of genital squamous-cell carcinomas. OBJECTIVE: The aim of this double-blind, placebo-controlled study was to compare and evidence differences in clinical efficacy and tolerance between human leukocyte interferon-alpha (2 x 10(6) IU/g) and podophyllotoxin (0.5%), incorporated in a hydrophilic cream base to cure genital warts in Asian males. METHODS: Sixty patients, circumcised, who ranged in age from 18 to 40 years (mean 25.0), diagnosed with the evidence of penoscopy and HPV DNA (Southern dot blot) as harboring 396 lesions (mean 6.6), were randomized to three parallel groups. Each subject was allocated a precoded tube (40 g) containing one of two trial preparations or matching placebo 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 regression of lesions was recorded as cured. Patients cured during the treatment were spared further therapy and were requested to visit us as scheduled for poststudy follow-up. RESULTS: Findings indicated that patients treated with leukocyte interferon-alpha cream had shown comparatively 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 body temperature (> 38 degrees C; 6.6%) were the most frequent adverse symptoms with no dropout. The study was followed up for 1 year, and out of 32/60 (53.3%) cured patients 3 had a relapse after 10 months. CONCLUSION: Leukocyte interferon-alpha (2 x 10(6) IU/g) has shown comparatively better results than 0.5% podophyllotoxin and placebo in a hydrophilic cream base, thus leukocyte interferon-alpha in cream may provide an alternative and effective regimen to treat genital warts in males.

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.

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 determine and compare the clinical efficacy and tolerance of human leukocyte alpha-interferon (incorporated 2 x 10(6) IU/g) in hydrophilic cream to cure genital warts. Preselected Asian female patients (n = 150) aged 18-40 years (mean 22.5), with the clinical and biopsy-confirmed diagnosis of genital warts (mean 2.64), predominantly flat vaginal condylomas, were randomly allocated to 3 parallel groups. Each patient was given a coded tube containing 80 g placebo/active preparation with a graduated applicator. Patients were instructed to inject 6 g of the either 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 (maximum 4 weeks active treatment). To assess the clinical efficacy patients were examined on a week-to-week basis. A total clearance of warts (biopsy-confirmed) was evaluated as a complete cure. Patients cured during the treatment were spared further treatment and were requested to visit us after 16 weeks for relapse control. As for the remaining patients, empty tubes were collected, and similarly coded replacement tubes 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 all the groups: 48% patients in group A, 90% patients in group B, and 10% patients in placebo groups taken as completely cured.(ABSTRACT TRUNCATED AT 250 WORDS)