BACKGROUND:Tinea capitis is a common childhood infection that has recently become more frequent in urban areas in Europe and the U.S.A. The current licensed treatment in children is griseofulvin 10 mg kg(-1) daily, which is usually given for 6--8 weeks. OBJECTIVES: To compare this treatment with a 4-week course of oral terbinafine. METHODS:Terbinafine was given at the following doses: in children weighing < 20 kg, 62.5 mg daily; 20--40 kg, 125 mg daily; > 40 kg, 250 mg daily. Two hundred and ten children aged 2--16 years, with mycologically confirmed tinea capitis, were randomized to 4 weeks treatment with terbinafine or 8 weeks with griseofulvin, and followed for a total of 24 weeks to determine the difference between treatments with respect to short- and long-term efficacy and tolerability. RESULTS:One hundred and forty-seven patients were evaluable (terbinafine 77, griseofulvin 70). Although the 4-week course of terbinafine resulted in a trend to more rapid clearance of tinea capitis, there were no statistically significant differences between the two drugs in terms of overall outcome or tolerability, apart from in a subgroup of patients with Trichophyton infections, and weighing > 20 kg, who responded better to terbinafine than to griseofulvin at 4 weeks. By contrast, there was a better response to griseofulvin than to terbinafine in patients with Microsporum audouinii infections. CONCLUSIONS: Overall, the study showed that 4 weeks of treatment with oral terbinafine has similar efficacy to 8 weeks of treatment with griseofulvin for the management of tinea capitis in children.
RCT Entities:
BACKGROUND:Tinea capitis is a common childhood infection that has recently become more frequent in urban areas in Europe and the U.S.A. The current licensed treatment in children is griseofulvin 10 mg kg(-1) daily, which is usually given for 6--8 weeks. OBJECTIVES: To compare this treatment with a 4-week course of oral terbinafine. METHODS:Terbinafine was given at the following doses: in children weighing < 20 kg, 62.5 mg daily; 20--40 kg, 125 mg daily; > 40 kg, 250 mg daily. Two hundred and ten children aged 2--16 years, with mycologically confirmed tinea capitis, were randomized to 4 weeks treatment with terbinafine or 8 weeks with griseofulvin, and followed for a total of 24 weeks to determine the difference between treatments with respect to short- and long-term efficacy and tolerability. RESULTS: One hundred and forty-seven patients were evaluable (terbinafine 77, griseofulvin 70). Although the 4-week course of terbinafine resulted in a trend to more rapid clearance of tinea capitis, there were no statistically significant differences between the two drugs in terms of overall outcome or tolerability, apart from in a subgroup of patients with Trichophyton infections, and weighing > 20 kg, who responded better to terbinafine than to griseofulvin at 4 weeks. By contrast, there was a better response to griseofulvin than to terbinafine in patients with Microsporum audouinii infections. CONCLUSIONS: Overall, the study showed that 4 weeks of treatment with oral terbinafine has similar efficacy to 8 weeks of treatment with griseofulvin for the management of tinea capitis in children.