PILOT-STUDY OF TERBINAFINE IN CHILDREN SUFFERING FROM TINEA-CAPITIS -EVALUATION OF EFFICACY, SAFETY AND PHARMACOKINETICS

In an open pilot study, 12 children with tinea capitis were treated fo r 6 weeks with oral terbinafine (125 mg/day), and followed up 2 weeks later. The study was conducted to evaluate the efficacy, safety and ph armacokinetics of terbinafine. All patients were completely cured at t he end of the treatment period, and there was no evidence of relapse a t follow-up. Seven had a negative culture after 3 weeks of treatment. The time to obtain culture conversion from positive to negative did no t appear to be related to body weight, but to clinical severity at bas eline. Terbinafine is well tolerated and safe over a 56-day period. Th e kinetic data show a higher clearance of terbinafine in children comp ared with adults, with shorter alpha- and beta-phase elimination half- lives. However, a longer terminal gamma-phase (at least 6 days) is obs erved, as in adults, after multiple dose administration, and this is r elated to elimination from the tissues. The plasma concentrations are comparable between children and adults at a steady state (125 mg/day).