A randomized double-blind comparative study of terbinafine and griseofulvin in tinea capitis

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).