Comparative study of the efficacy and tolerability of 4 weeks of terbinafine therapy with 8 weeks of griseofulvin therapy in children with tinea capitis

BACKGROUND: Ringworm of the scalp is a dermatophyte infection prevalent in pre-school and school-aged children. Tinea capitis is one of the few superficial fungal infections that does not adequately respond to topical treatment and requires 6-8 weeks of oral antifungal therapy. The aim of this double-blind study was to compare the efficacy and tolerability of terbinafine therapy with griseofulvin therapy in children with mycologically proven tinea capitis. METHODS: In a randomized, double-blind study, efficacy and tolerability of terbinafine given orally once daily for 4 weeks were compared with those of griseofulvin given orally once daily for 8 weeks. A total of 78 subjects were enrolled (39 in the terbinafine group, and 39 in the griseofulvin group). Among these, 7 subjects in the terbinafine group and 4 subjects in the griseofulvin group dropped out. The study included 67 subjects (32 in the terbinafine group and 35 in the griseofulvin group) and the mean age was 7.0 years (range 2-13 years) in the terbinafine group and 6.6 years (range 2-12 years) in the griseofulvin group. Clinical and mycological examination of hair samples were performed at the initial clinical assessment and after the 2nd, 4th, 6th, 8th and 12th weeks. Biochemical and haematological parameters were measured at the initial clinical assessment and after weeks 4, 8 and 12. RESULTS: At the final follow-up visit (week 12), a mycological cure was recorded in 88.0% of the terbinafine-treated group, compared with 91.0% of the griseofulvin-treated group. Effective treatment (complete disappearance of signs and symptoms and negative mycology, or not more than two signs or symptoms of mild erythema, desquamation or pruritus) was recorded in 78% of subjects in the terbinafine-treated group compared with 74% of subjects in the griseofulvin-treated group. Trichophyton species and Microsporum canis showed similar responsiveness to terbinafine treatment. CONCLUSION: Terbinafine given for 4 weeks was well tolerated and was as effective as griseofulvin used for 8 weeks in the treatment of tinea capitis in children