Treatment of molluscum contagiosum in males with an analog of imiquimod 1% in cream: a placebo-controlled, double-blind study.

The objective of this double-blind, placebo-controlled study was to evaluate in males the clinical efficacy in treating molluscum contagiosum and tolerance of an analog of imiquimod (1%) in cream. One hundred patients between 9 and 27 years of age (mean 16.3), with 733 lesions (mean 7.3), whose size ranged from 2 to 5 mm diameter (mean spot size 3.4 mm) and a biopsy-confirmed diagnosis of molluscum contagiosum were randomized into two parallel groups. In a double-blind manner, precoded 40-g tubes were dispensed. Patients self-administered the trial medication to their lesions at home three times daily for five consecutive days per week. The study was scheduled with 4 weeks of active treatment (maximum 60 topical applications) and 12 months (on a monthly basis) of follow-up. Patients were examined on a weekly basis. Thirteen patients had atopic dermatitis. A clinically and histopathologically confirmed total elimination of lesions was considered as cured. After four weeks of treatment, 49 patients and 372 lesions were cured. Breaking the code revealed that imiquimod cream had cured 82% of the patients and 86.3% of the lesions. Placebo cleared 16% of the patients and 63 of the lesions (p < 0.0001). During the treatment, 88% of the patients experienced no allergic, localized, or drug-related adverse symptoms. Twelve patients, predominantly in the imiquimod cream group reported non-objective, drug-induced, mild reactions with no dropouts. The study was followed-up for 12 months. Among 49 cured patients, 3 had relapses after 10 months. In conclusion, the study demonstrated that 1% imiquimod analog in cream with mild subjective side effects is significantly more efficacious than the placebo in curing molluscum contagiosum in males.

RCT Entities:   Population Interventions Outcomes