A comparative double-blind study of terbinafine (Lamisil) and griseofulvin in tinea corporis and tinea cruris

Abstract

In a double-blind randomized study, 92 patients with culturally proven tinea corporis and/or tinea cruris were treated orally with either terbinafine (Lamisil) (125 mg b.i.d.) or griseofulvin (500 mg b.i.d.) for up to 6 weeks. The two groups of patients and distribution of the target lesions were similar, but the analysis of the clinical scores showed that the terbinafine group had slightly higher mean scores at baseline (P = 0.186). At the end of therapy the proportion of patients with negative microscopy and culture was 78% in the terbinafine group and 83% in the griseofulvin-treated group. At the assessment 8 weeks after the end of therapy the percentages of terbinafine- and griseofulvin-treated patients with negative mycology were 93 and 95%, respectively. There were three relapses after mycological cure in the griseofulvin group (8%) and two in the terbinafine group (4%). Griseofulvin-treated patients were treated for shorter periods than terbinafine-treated patients (i.e. 58% compared to 26% received only 2-4 weeks of therapy). In terms of overall effectiveness, there were no significant differences between the two treatments. Thirty-seven terbinafine patients (77%) compared to 36 griseofulvin patients (82%) had overall effective therapy. Eight terbinafine patients (16%) compared to 10 griseofulvin patients (20%) experienced at least one adverse event. Five patients in the terbinafine group and six in the griseofulvin group had to stop the treatment due to headaches or gastrointestinal disorders. One terbinafine patient had an elevation of liver function tests after 6 weeks of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Adverse Drug Reactions to Systemic Antifungals Prevention and Management

“…Complaints reported by investigators have included nausea, dyspepsia, abdominal pain or cramping, stomach pains, diarrhoea, and soft or frequent stools (Cole & Stricklin 1989;Del Palacio et al 1990;Goodfield et al 1989;Hay et al 1991;Savin 1989;Savin & Zaias 1990; Villars ;Zaias 1990), which rarely required discontinuation of the drug (Del Palacio et al 1990;Goodfield et al 1989;Hay et al 1991).…”

Update on terbinafine with a focus on dermatophytoses

“…84 Following oral administration for the treatment of tinea corporis and tinea cruris, clinical and mycological cure rates observed with terbinafi ne have ranged from 71% to 100% and 78% to 100%, respectively. 78,[87][88][89] No signifi cant differences in mycological or clinical cure rates were observed between terbinafi ne and griseofulvin in these studies; [87][88][89] however, higher relapse rates were observed with griseofulvin. 88,89 Tinea imbricata, a variant of tinea corporis found predominantly in tropical countries, manifests as concentric rings of papular plaques that are chronic in nature and relatively recalcitrant to antifungal therapy.…”

“…78,[87][88][89] No signifi cant differences in mycological or clinical cure rates were observed between terbinafi ne and griseofulvin in these studies; [87][88][89] however, higher relapse rates were observed with griseofulvin. 88,89 Tinea imbricata, a variant of tinea corporis found predominantly in tropical countries, manifests as concentric rings of papular plaques that are chronic in nature and relatively recalcitrant to antifungal therapy. In a single randomized, controlled trial 4 weeks of treatment with terbinafi ne demonstrated higher overall effi cacy rates (100%) and lower relapse rates (16%) as compared with itraconazole (89% effi cacy, 75% relapse).…”

Difference in Percutaneous Absorption and Intracutaneous Distribution in Guinea Pigs among Topical Antifungal Drugs (Tioconazole Solution, Tioconazole Cream, Miconazole Nitrate Solution and Bifonazole Solution)

“…The efficacy and safety of twice or three times a day topical preparations of TCZ solution appear to be similar to those of TCZ cream and clotrimazole solution. [15][16][17][18] Pharmacokinetic studies in rats have demonstrated minimal systemic exposure following dermal application of TCZ cream.2) After a single application of TCZ cream about 16% of the applied radioactivity penetrates into rat skin and the percutaneous penetration into swine skin is considerably higher than that of clotrimazole cream.19) BFZ also penetrates far better into human skin than clotrimazole. 20) Clinical trials have clearly demonstrated the efficacy and safety of various formulations of BFZ applied once a daily in the treatment of superficial fungal infections of the skin.…”

“…The efficacy and safety of twice or three times a day topical preparations of TCZ solution appear to be similar to those of TCZ cream and clotrimazole solution. [15][16][17][18] Pharmacokinetic studies in rats have demonstrated minimal systemic exposure following dermal application of TCZ cream.…”