Abstract
An open, clinical, pilot study showed terbinafine to be effective and well tolerated by patients suffering from tinea capitis. On the basis of those results a study comparing efficacy and tolerability of terbinafine, taken for 4 weeks, with those of griseofulvin taken for 8 weeks, was carried out. The treatment periods were separated by a 4-week placebo wash-out phase. Treatment was administered once daily in the evening according to the patient's body weight. The therapeutic efficacy of the drugs was determined by evaluation every 2 weeks for clinical signs and symptoms and by mycological examination of clinical material. The clinical parameters were assessed according to a four-point scale ranging from 0 (absent) to 3 (severe). Of 105 evaluable patients (49 males and 56 females), 56 were treated with terbinafine and 49 with griseofulvin. Fungi isolated included: Trichophyton violaceum (n = 92), T. verrucosum (n = 7), T. tonsurans (n = 4), T. rubrum (n = 1) and Microsporum audouinii (n = 1). Final evaluation at week 12 showed a cure rate of 93% and 80% in the terbinafine and griseofulvin treatment groups, respectively. Adverse effects noted (terbinafine n = 5, griseofulvin n = 7) were not drug related. It appears that short-term (4 weeks) terbinafine treatment is as effective as 8 weeks griseofulvin therapy, and both are safe especially in children (94/105).
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