Journal of the American Academy of Dermatology
Greer and Jolly ery, development, and evaluation of antifungal agents.
Barcelona: JR Prous, 1987:511-20. 8. Savin R. Successful treatment of chronic tinea pedis (mocassin type) with terbinafine (Lamisil). Clin Exp Dermatol 1989;14:116-9. 9. Zaias N, Serrano L. The successful treatment of finger Trichophyton rubrum onychomycosis with oral terbinafine. Clin Exp DermatoI1989;14:120-3. 10. Greer D, Millikan L, Jolly H. Effect of topical SF 86-327 1% cream in treatment of tinea cruris/tinea corporis [Ab-
stract], Presented at the Seventeenth World Congress of Dermatology, Berlin, 1989:130. 11. Kagawa S. Clinical efficacy of terbinafine in 629 Japanese patients with dermatomycoses. Clin Exp Dermatol 1989; 14:114-5. 12. Villars Y, Jones TC. Clinical efficacy and tolerability of terbinafine (Lamisil)-a new topical and systemic fungicidal drug for treatment of dermatomycoses. Clin Exp DermatoI1989;14:124-7.
Treatment of chronic moccasin-type tinea pedis with terbinafine: A double-blind, placebo-controlled trial Ronald C. Savin, MD, a and Nardo Zaias, MDb New Haven, Connecticut, and Miami Beach, Florida Terbinafine is an orally and topically active fungicidal drugof the allylamine series. Its oral efficacy at 125 mg taken twice daily was evaluated in a randomized, double-blind, placebo-controlled study inmoccasin-type tineapedis. Thestudywas conducted simultaneously intwo centers andconsisted of41 evaluable cases (23terbinafine, 18placebo). Mycologic cure and near to complete clearing of signs and symptoms were obtained in 59% of the terbinafmetreated patients after 6 weeks of treatment and in 65% at 2 weeks after treatment. Corresponding efficacy forplacebo-treated patientswaszero at both evaluations. Sideeffects in both groups were minimal. We conclude that terbinafine is welltolerated and highly effective in moccasin-type tinea pedis. (J AM ACAD DERMATOL 1990;23:804-7.)
In vitro tests have shown terbinafine to be more effective than other currently available antifungal agents against dermatophytes,' and the clinical efficacy of oral terbinafine has been demonstrated in onychomycosis.' tinea corporis and cutaneous candidiasis.' and chronictinea pedis(plantar type). 4 In the small comparative trial of the treatment of moccasin-type tinea pedis, oral terbinafine was significantly more effective than griseofulvin." However, no double-blind, placebo-controlled trials in this indication have yet been reported. This study was undertaken to evaluate the efficacy and safety of oral terbinafine in a double-blindcomparison to placebo in chronic moccasin-type tinea pedis. From the Department of Dermatology, Yale University School of Medicine, New Haven,' and Mt. Sinai Medical Center, Dermatology, Miami Beach." Supported in part by an educational grant fromSandozPharmaceuticals Corp., East Hanover, N.J. Reprint requests: Ronald C.Savin, MD, 123 YorkStreet, NewHaven. CT 06511. 16/0/23524
804
MATERIAL AND METHODS Fifty patients with clinically suspected moccasin-type tinea pedis wereentered intothe study in twotreatment centers. The diagnosis was provisionally confirmed microscopically by the presence of hyphae in a KOH wet mount. Onlypatients older than 18 years whohad previously failed to respond to topical treatment or whose lesions precluded theuseoftopical therapywereeligible. Women of childbearing potential were included in the study only if they wereusing a reliable form of birth control. However, women whowere breast-feeding or pregnant were excluded. Other initial exclusion criteriawerediseases of the digestive system, any condition that might impair gastrointestinal absorption, renal or hepatic disease, or any blood disease. Radiotherapy, treatment withcytostatic or immunosuppressant drugs, or the use of antibiotics, antifungals, antivirals, or antiparasitic agents within the 2 weeks preceding the studywerealso causes for exclusion. Patients wererandomly allocated to active (oralterbinafine, 125 mg) or placebo groups and were treated in double-blind fashion twicedaily for a period of 6 weeks. Patients were instructed to avoid application of any
Volume 23 Number 4, Part 2 October 1990
Treatment ofchronic moccasin-type tinea pedis 805 100 90
'0 ell
1~='NEI
so
~
70
~ GI
60
...::::
50
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Greer and Jolly ery, development, and evaluation of antifungal agents.
Barcelona: JR Prous, 1987:511-20. 8. Savin R. Successful treatment of chronic tinea pedis (mocassin type) with terbinafine (Lamisil). Clin Exp Dermatol 1989;14:116-9. 9. Zaias N, Serrano L. The successful treatment of finger Trichophyton rubrum onychomycosis with oral terbinafine. Clin Exp DermatoI1989;14:120-3. 10. Greer D, Millikan L, Jolly H. Effect of topical SF 86-327 1% cream in treatment of tinea cruris/tinea corporis [Ab-
stract], Presented at the Seventeenth World Congress of Dermatology, Berlin, 1989:130. 11. Kagawa S. Clinical efficacy of terbinafine in 629 Japanese patients with dermatomycoses. Clin Exp Dermatol 1989; 14:114-5. 12. Villars Y, Jones TC. Clinical efficacy and tolerability of terbinafine (Lamisil)-a new topical and systemic fungicidal drug for treatment of dermatomycoses. Clin Exp DermatoI1989;14:124-7.
Treatment of chronic moccasin-type tinea pedis with terbinafine: A double-blind, placebo-controlled trial Ronald C. Savin, MD, a and Nardo Zaias, MDb New Haven, Connecticut, and Miami Beach, Florida Terbinafine is an orally and topically active fungicidal drugof the allylamine series. Its oral efficacy at 125 mg taken twice daily was evaluated in a randomized, double-blind, placebo-controlled study inmoccasin-type tineapedis. Thestudywas conducted simultaneously intwo centers andconsisted of41 evaluable cases (23terbinafine, 18placebo). Mycologic cure and near to complete clearing of signs and symptoms were obtained in 59% of the terbinafmetreated patients after 6 weeks of treatment and in 65% at 2 weeks after treatment. Corresponding efficacy forplacebo-treated patientswaszero at both evaluations. Sideeffects in both groups were minimal. We conclude that terbinafine is welltolerated and highly effective in moccasin-type tinea pedis. (J AM ACAD DERMATOL 1990;23:804-7.)
In vitro tests have shown terbinafine to be more effective than other currently available antifungal agents against dermatophytes,' and the clinical efficacy of oral terbinafine has been demonstrated in onychomycosis.' tinea corporis and cutaneous candidiasis.' and chronictinea pedis(plantar type). 4 In the small comparative trial of the treatment of moccasin-type tinea pedis, oral terbinafine was significantly more effective than griseofulvin." However, no double-blind, placebo-controlled trials in this indication have yet been reported. This study was undertaken to evaluate the efficacy and safety of oral terbinafine in a double-blindcomparison to placebo in chronic moccasin-type tinea pedis. From the Department of Dermatology, Yale University School of Medicine, New Haven,' and Mt. Sinai Medical Center, Dermatology, Miami Beach." Supported in part by an educational grant fromSandozPharmaceuticals Corp., East Hanover, N.J. Reprint requests: Ronald C.Savin, MD, 123 YorkStreet, NewHaven. CT 06511. 16/0/23524
804
MATERIAL AND METHODS Fifty patients with clinically suspected moccasin-type tinea pedis wereentered intothe study in twotreatment centers. The diagnosis was provisionally confirmed microscopically by the presence of hyphae in a KOH wet mount. Onlypatients older than 18 years whohad previously failed to respond to topical treatment or whose lesions precluded theuseoftopical therapywereeligible. Women of childbearing potential were included in the study only if they wereusing a reliable form of birth control. However, women whowere breast-feeding or pregnant were excluded. Other initial exclusion criteriawerediseases of the digestive system, any condition that might impair gastrointestinal absorption, renal or hepatic disease, or any blood disease. Radiotherapy, treatment withcytostatic or immunosuppressant drugs, or the use of antibiotics, antifungals, antivirals, or antiparasitic agents within the 2 weeks preceding the studywerealso causes for exclusion. Patients wererandomly allocated to active (oralterbinafine, 125 mg) or placebo groups and were treated in double-blind fashion twicedaily for a period of 6 weeks. Patients were instructed to avoid application of any
Volume 23 Number 4, Part 2 October 1990
Treatment ofchronic moccasin-type tinea pedis 805 100 90
'0 ell
1~='NEI
so
~
70
~ GI
60
...::::
50
;::.
~
~ '6 a. .!
~
