Objective-To compare the efficacy and safety of terbinafine 1% cream a
nd clotrimazole 1% cream in the treatment of tinea pedis. Design-Multi
centre, double blind parallel group study. Setting-32 general practice
s and one hospital. Patients-256 patients with mycologically confirmed
tinea pedis. Of the 211 patients evaluable, 107 were randomised to te
rbinafine (75 male, 32 female; mean (range) age 40 (12-81) years) and
104 to clotrimazole (79 male, 25 female; mean (range) age 36 (12-71) y
ears). Interventions-Terbinafine 1% cream applied twice daily for one
week and inert cream applied twice daily for the next three weeks. Clo
trimazole 1% cream applied twice daily for four weeks. Main outcome me
asures-Mycological cure (negative results on microscopy and culture) a
nd effective treatment (mycological cure plus no or minimal signs and
symptoms) measured at weeks 1, 2, 3, 4, and 6. Results-At week four ra
tes of mycological cure were 93.5% for terbinafine and 73.1% for clotr
imazole (p=0.0001); and at week six 97.2% for terbinafine and 83.7% fo
r clotrimazole (p=0.001). Rates of effective treatment at week 4 were
89.7% for terbinafine and 58.7% for clotrimazole (p=0.0001); and 89.7%
for terbinafine and 73.1% for clotrimazole (p=0.002) at week 6. Concl
usion-These results indicate that a one week course of terbinafine 1%
cream is more effective in the treatment of tinea pedis than a four we
ek course of clotrimazole 1% cream, both in terms of mycological cure
and effective treatment.