Human leukocyte derived interferon-alpha in a hydrophilic gel for the treatment of intravaginal warts in women: a placebo-controlled, double-blind study

This placebo-controlled, double-blind study was aimed to evaluate the clini cal efficacy, safety and tolerability of human leukocyte interferon-alpha ( 2 x 10(6) IU/g) incorporated in a hydrophilic gel (hydroxyethylcellulose, 1 %) to cure intravaginal warts in women. Preselected, subjects (n=60) who ra nged between 18 and 50 years of age (mean 23.7), harbouring 275 vaginal war ts (mean 4.6) with clinical, histopathological and polymerase chain reactio n (PCR) confirmed diagnosis of human papillomavirus (HPV) infections were r andomly divided into 2 parallel groups. A preceded tube (45 g), active or p lacebo, with disposable applicators and instructions was given to each pati ent for one week's usage. Patients were demonstrated how to inject 4 g of t he trial medication deep into the vagina 2 times daily for 5 consecutive da ys per week. During the 4-week treatment period, patients were examined on a weekly basis. Cure was defined as absence of clinical signs of infection, as well as PCR and Southern blot hybridization confirmed negative HPV DNA on molecular assay. By the cessation of the therapy 41.7% patients and 44.4 % intravaginal warts were cured. Code disclosure revealed that interferon-a (2 x 10(6) IU/g) in gel had cured 73.3% patients, and 79.3% intravaginal w arts, while placebo healed 10% patients and 8.1% lesions (active gel versus placebo; P<0.0001). Fifty-one patients (85%) complained of no drug-related adverse reactions. Nine patients (15%) mostly in the interferon-alpha gel experienced non-objective, mild headache, tenderness, with transient increa se in their body temperature (>38 degrees C). Ln conclusion, the findings s howed that along with non-objective mild side effects, human leukocyte inte rferon-alpha (2 x 10(6) IU/g) in a hydrophilic gel is significantly more ef fective than placebo to cure intravaginal warts in women.