Which drug is most effective in treating childhood tinea capitis caused by Microsporum species?

Question What is the optimum duration for oral terbinafine therapy when treating children with tinea capitis caused by Micro-sporum species? How do these terbinafine dose schedules compare in effectiveness to griseofulvin? Design: Four double-blind duration-finding terbinafine arms were compared with an unblinded griseofulvin arm. Each arm was parallel, and patients were randomly allocated. The study duration was 12 weeks with a 4-week follow-up. Mycological assessment and clinical assessment were performed at entry, every 2 weeks, and at follow-up. Clinical signs assessed were erythema, scaling, papules, pustules and pruritis. Each was rated on a scale of 0 (absent) to 3 (severe), and individual scales were summed at each assessment. Direct mycological microscopy was performed at each visit to the local centre. Cultures were taken at the initial and all subsequent visits, and referred to a central laboratory. The study was sponsored by the manufacturer of terbinafine. Patients: 165 children with Microsporum tinea capitis proven by culture. Their mean age was 7.7 years, 67% weighed 20–40 kilograms, and 77% of patients were white. Patients in each arm seemed similar. Interventions: The 4 terbinafine arms were double blinded. Terbinafine dosage was based on a patient bodyweight formula (62.5 mg/day if < 20 kg, 125 mg/day if 20–40 kg and 250 mg/day if > 40 kg bodyweight). Patients in Arm 1 had 6 weeks terbinafine treatment plus 6 weeks placebo; those in Arm 2 had 8 weeks terbinafine plus 4 weeks placebo; those in Arm 3 had 10 weeks terbinafine plus 2 weeks placebo; those in Arm 4 had 12 weeks terbinafine treatment; and those in Arm 5 had 12 weeks griseofulvin (oral suspension) at 20 mg/kg/day, and this arm was unblinded. Main outcome measure: Complete cure (CC) was assessed as negative results on mycological studies and no clinical signs at the finish. Effective treatment (ET) was assessed as negative culture and a clinical score of < 2 at the finish; clinical cure was absence of signs and symptoms; mycological cure was negative microscopy and negative culture. The primary efficacy was CC rate at the end of the study. Main results: In 134 intention-to-treat patients, 6 weeks of terbinafine therapy gave 62% CC and 62% ET, 8 weeks gave 60% CC and 63% ET, 10 weeks gave 48% CC and 59% ET, and 12 weeks gave 43% CC and 52% ET. This compared with 84% CC and 88% ET for 12 weeks of therapy …