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

Abstract

In an open pilot study, 12 children with tinea capitis were treated for 6 weeks with oral terbinafine (125 mg/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 alpha- and beta-phase elimination half-lives. However, a longer terminal gamma-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).

Efficacy of Itraconazole Versus Terbinafine for the Treatment of Tineacruris.

“…However, all 9 non-responders had this dermatophyte, suggesti ng that the durati on of therapy has to be extended beyond 2 weeks in certain cases of T. rubrum infecti on. Although the number of cases resulti ng from other pathogens was small, they do respond to this short-term therapy with drug usually in Tenia capiti s. [6][7][8][9][10][11][12][13] Bothitraconazole and terbinafi ne are highly lipophilic and kerati nophilic. They persist in the stratum corneum and hair in high concentrati ons for 3-4 weeks aft er therapy is disconti nued.…”

Human Pharmacogenomic Variations and Their Implications for Antifungal Efficacy

“…A significant negative correlation between the mean blood concentration of ketoconazole and age has been reported (185). Terbinafine AUC values are significantly higher in children than in young adults (194), although in a separate study, higher plasma concentrations and lower half-lives of the terminal elimination phase were reported (127). For fluconazole, the volume of distribu-tion is greater in neonates and decreases in young adults (31), the mean plasma half-life in children (22 h) is shorter than in adults (37 h) (59), and total clearance is greater in children (1.16 liters/h) than in adults (1.07 liters/h) (163).…”

Antifungal agents for common outpatient paediatric infections

“…It is effective for children with tinea capitis at a dose of 62.5 mg/day to 250 mg/day for four weeks (44)(45)(46)(47)(48). Topical terbinafine 1% formulations have been effective when applied once or twice daily for two weeks.…”