MedWire News: Terbinafine hydrochloride is an effective alternative to griseofulvin for the treatment of Trichophyton tonsurans but not Microsporum canis tinea capitis, study findings suggest.
Griseofulvin is considered the gold standard of care in the treatment of tinea capitis. However, treatment failures have become more common over the past few decades, and increasingly higher doses and longer durations of therapy are necessary for effective treatment.
"These patterns may reflect development of resistance to griseofulvin and/or a change in causative pathogens," explain Boni Elewski (University of Alabama at Birmingham School of Medicine, USA) and colleagues.
Alternative antifungal agents with shorter and simpler treatment regimens are therefore needed. Terbinafine hydrochloride oral granules have been developed as a new pediatric formulation comprising miniature granules that can be sprinkled over food and easily swallowed.
Boni and team compared the efficacy and tolerability of this new pediatric formulation with griseofulvin oral suspension in the treatment of children with tinea capitis.
Two identical multicenter studies conducted between June 2004 and April 2006 randomly allocated 1549 children aged 4-12 years to receive either terbinafine 5-8 mg/kg (n=1040) or griseofulvin 10-20 mg/kg (n=509) for a treatment period of 6 weeks followed by 4 weeks of follow-up.
Based on the pooled data, the complete cure rate at the end of follow-up was significantly higher in the terbinafine group (45.1%), compared with the griseofulvin group (39.2%). The mycologic cure rate was also significantly greater for terbinafine than for griseofulvin (61.5% vs 55.5%).
The clinical cure rate at the end of follow-up was higher in patients treated with terbinafine than in those receiving griseofulvin (63.0% vs 58.8%); however, the difference was not significant.
Subgroup analyses demonstrated that terbinafine was significantly better than griseofulvin for complete, mycologic, and clinical cure rates among patients with T. tonsurans but not M. canis tinea capitis. Among patients with M. canis tinea capitis, griseofulvin was significantly better than terbinafine for mycologic and clinical cure rates.
Adverse events were reported by approximately 50% of patients in each treatment group; however, almost all events were mild or moderate in severity. The most frequently reported adverse events in both treatment groups were nasopharyngitis, headache, and pyrexia.
Writing in the Journal of the American Academy of Dermatology, the researchers conclude: "The present findings add to accumulating evidence of the safety and effectiveness of terbinafine as an antifungal agent and indicate that the new formulation of terbinafine oral granules may also be a safe and effective treatment for tinea capitis in children."
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