PHARMACOKINETIC AND SAFETY PROFILE OF TOPICAL PODOPHYLLOTOXIN (0.5-PERCENT SOLUTION) ON MOLLUSCUM CONTAGIOSUM IN CHILDREN

The aim of this study was to determine the pharmacokinetic profile of a 0.5% solution podophyllotoxin in children after applications on moll uscum contagiosum. Eight children (age range 34 months to 14 years) re ceived 15 to 40 applications of 5.4 mu l once daily and had to be trea ted for 7 to 30 days. Seven serum samples for podophyllotoxin assay we re scheduled at day 1 and one at day 7. Podophyllotoxin in the serum w as assayed using high performance liquid chromatography. Blood liver e nzymes were also tested before the first administration and again at d ay 7. Podophyllotoxin concentrations remained below the quantification limit (0.50 ng/ml) at day 1 and day 7 for all but one patient, in who m a small peak at 0.70 ng/ml was measured 105 min after the first appl ication (day 1) of 216 mu l on 40 lesions. In addition to this negligi ble systemic absorption of the drug after topical administration, no s ignificant variation was observed for liver enzymes and no serious adv erse effects were reported. Five patients were considered evaluable ca ses for efficacy of which 3 had good (disappearance of more than 50% o f treated lesions) responses. These results are interesting and provid e support for a placebo-controlled study to confirm the efficacy and s afety of a 0.5% podophyllotoxin solution in the treatment of molluscum contagiosum in children.