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.