CHICAGO A new oral formulation of the antifungal drug terbinafine significantly improved tinea capitis in children aged 4-12 years compared with griseofulvin oral suspension, based on efficacy data from 1,286 children in the largest study of the medication to date.
These findings were presented in a poster by Dr. Sheila Friedlander at the annual meeting of the Society for Pediatric Dermatology.
Children with confirmed positive cultures for tinea capitis who were randomized to receive terbinafine had a significantly higher complete cure rate (combined mycologic and clinical cure rates) after 6 weeks of daily treatment and 10 weeks of follow-up, compared with those who received griseofulvin (45% vs. 39%), said Dr. Friedlander, a pediatric dermatologist at the University of California, San Diego Medical Center.
The new terbinafine formulation (Lamisil oral granules) consists of coated granules that can be sprinkled on food so children can swallow them easily. Both terbinafine and griseofulvin are dosed by body weight. The study was supported in part by Novartis Pharmaceuticals Corp.
Adverse event rates were similar between the two groups. About half of the patients in each group reported at least one adverse event, but almost all were mild or moderate; only 1.6% of the terbinafine patients and 1.2% of the griseofulvin patients discontinued their medications because of adverse events. The most common complaints included vomiting, diarrhea, headache, and abdominal pain.
The mycologic cure rate alone was significantly higher in the terbinafine group compared with the griseofulvin group (62% vs. 56%). The clinical cure rate alone was higher, but not significantly higher, in the terbinafine group compared with the griseofulvin group (63% vs. 59%). Terbinafine was most effective against Trichophyton tonsurans, which is the organism most often associated with tinea capitis, Dr. Friedlander and her associates wrote.