Pilot study of terbinafine in children suffering from tinea capitis: evaluation of efficacy, safety and pharmacokinetics


Dr H.Humbert, Research and Development, Laboratoires Sandoz. 14 Boulevard Richelieu, 92506 Rueil-Malmaison, Cedex, France.


In an open pilot study, 12 children with tinea capitis were treated for 6 weeks with oral terbinafine (125mg/day), and followed up 2 weeks later. The study was conducted to evaluate the efficacy, safety and pharmacokinetics of terbinafine.

All patients were completely cured at the end of the treatment period, and there was no evidence of relapse at follow-up. Seven had a negative culture after 3 weeks of treatment. The time to obtain culture conversion from positive to negative did not appear to be related to body weight, but to clinical severity at baseline. Terbinafine is well tolerated and safe over a 56-day period. The kinetic data show a higher clearance of terbinafine in children compared with adults, with shorter α- and β-phase elimination half-lives. However, a longer terminal 7-phase (at least 6 days) is observed, as in adults, after multiple dose administration, and this is related to elimination from the tissues. The plasma concentrations are comparable between children and adults at a steady state (125 mg/day).