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Original Article
Treatment Outcome and Relapse with Short-term Oral Terbinafine 250 mg/day in Tinea Pedis Iwao Takiuchi 1, Nobuaki Morishita 1, Taizo Hamaguchi 2, 1 Department of Dermatology, Showa University Fujigaoka Hospital 1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa 227-8501, Japan 2 Department of Dermatology, Showa University, Northern Yokohama Hospital 35-1 Chigasakichuo, Tsuzuki-ku, Yokohama, Kanagawa 224-8503, Japan Received: 22, February 2005. Accepted: 15, July 2005 Abstract
A total of 168 patients with tinea pedis, but without onychomycosis, were treated with 1 cycle of mg/day for 1 week . KOH preparation for direct microscopy was performed 4, 8 and 12 weeks after starting therapy to determine if testing was positive for tinea. Patients with no negative results on KOH examination or no evidence of obvious clinical improvement at 8 weeks, another cycle of the therapy was prescribed. The cure, no cure, dropout, and discontinuation/unevaluable rates were 89.3%, 4.8%, 4.8% and 1.2%, respectively. The number of cycles required for cure in the plantar type was 1 cycle in 65.9% and 2 cycles in 54.5% of cases; in the interdigital type, 1 cycle in 79.1% and 2 cycles in 20.9% of cases; and mixed type, 1cycle in 29.1% and 2 cycles in 60.9% cases. Among patients who were followed for at least 3 years after cure, the relapse rates were about 10% each year: 1 year, 11.3%; 2 years, 8.9%; and 3 years, 11.2%. The relapse rate of about 10% each year over a 3-year period suggests that reinfection may be likely. Key words: oral terbinafine, treatment outcome, relapse rate, tinea pedis
Introduction
Patients and Methods
When treating tinea unguium using terbinafine Over a 5-year period from January 1998 to TBF , we have noticed that accompanying tinea December 2002, 168 patients diagnosed with tinea pedis is very easily treated, and recurrence is pedis, based on clinical features and KOH rare. In other countries, there have been many examination, were treated with 1 cycle of oral reports on the therapeutic effects of oral TBF terbinafine TBF 1 cycle defined as 250 mg/day on tinea pedis 1 4 . However, few reports of oral for 1 week by the Department of Dermatology, TBF for tinea pedis have been published in Showa University Fujigaoka Hospital.
Japan because the use of TBF for tinea pedis The patients in this study had no evidence of of conventional form is not covered by health onychomycosis. Of the 168 patients with tinea We now report treatment outcome in these interdigital-type and the remaining 24 had both patients. In addition, among patients who were plantar- and interdigital-type mixed-type .
followed for at least 3 years after cure, relapse Follow-up examinations at 4, 8 and 12 weeks after starting treatment included clinical and KOH examination. In general, regardless of the findings on KOH examination at 4 weeks, KOH examination was again performed at 8 weeks to 1-30 Fujigaoka Aobaku Yokohama, 227-8501, Japan determine if testing was positive for tinea. In Department of Dermatology, Showa University Fujigaoka patients with no negative results on KOH examination or no evidence of obvious clinical dropouts are excluded, the cure rate was improvement at 8 weeks, another cycle of the 93.8% and the no cure rate was 5.0%. The discontinued and unevaluable rates were both In the present study, cure was defined as follows: at either 8 or 12 weeks after the start of Of the 150 patients cured of tinea pedis, 84 treatment, improved clinical symptoms were seen, had the plantar type, 43 had the interdigital and KOH examinations of scales collected from type and 23 had the mixed type Table 2 . several places and stratum corneum samples harvested using a scalpel under a microscope plantar type, 9 with the interdigital type and 14 did not show any fungal elements. Continued with mixed type received two treatment cycles negative results on KOH examination at 12 weeks, even in the absence of marked improvement Of the 8 patients without a cure, 1 patient on clinical examination, was also defined as a judged as having a cure 8 weeks after cycle 1 cure. Positive results on KOH examination at of treatment had a relapse 1 month later. In 12 weeks or later after starting treatment, each of the other patients, KOH examination regardless of whether clinical examination showed was positive at 4 to 8 weeks after cycle 2 of treatment. Five of the patients had the interdigital Treatment in these patients was changed. type, 2 had both the interdigital and plantar To evaluate relapse in patients judged as cured, an attempt was made to schedule follow- There were 115 patients who were followed up evaluations including KOH examination. for at least 3 years after completing treatment. The presence or absence of a relapse in the Figure 1 depicts the changes in relapse rates patients who achieved a cure was evaluated by from 1 to 3 years in these patients. At 1 year, a clinic visit or contacting the patient by phone or e-mail each year from late August to early relapse, 13 11.3% had a relapse, and in one September. Eighty two of the patients were 0.9% , the status was unknown. At 2 years, evaluated through contact by phone or e-mail; the other 68 patients were evaluated at a clinic relapse, 9 8.9% had a relapse, and the status was unknown in 3 3.0% . At 3 years, 74 of 89 patients had a relapse, and in 5 5.6% , the status was The results of the 168 patients treated with oral TBF are summarized in Table 1. Treatment Of the 115 patients followed for at least 3 years, there were 58 cases of plantar type, 16 cases of interdigital type and 21 cases of mixed started treatment but did not return to clinic type. The number of relapses over 3 years was for follow-up. Treatment was discontinued or 15 in the plantar type, 15 in the interdigital Discussion
Table 1. Treatment outcome of tinea pedis with intermittent In addition to clinical examination and KOH examination by direct microscopy, culture findings have been regarded as essential to evaluate a cure . However, not all lesions can be cultured or examined with KOH, so complete evaluation of microbiological cure is nearly impossible. A better clinical indicator is whether the patient again develops tinea pedis the following summer 1 . Table 2. Number of cures for each tinea pedis clinical type Table 3. Number of cycles of treatment until cure In the present study, we decided to use a the data reported in these 2-week continuous marked improvement on clinical examination treatment studies. However, in our treatment and findings on KOH examination as evaluation regimen, an additional cycle of therapy was criteria for cure . Even if KOH examination was prescribed only when clinical or KOH examination positive, mycological culture of skin materials after 8 weeks showed no obvious improvement. was not performed from all patients as a basis As shown in Table 3, among patients with a for initial diagnosis. We cannot deny that there cure, 29 with the plantar type, 9 with the was a slightly insufficient basis for the initial interdigital type and 14 with the mixed type received two cycles of treatment. However, in 7 The cure no cure and dropout rates in our cases with the plantar type, 3 of the interdigital study were 89.3%, 4.8%, and 4.8%, respectively type and 4 of the mixed type, KOH examination Table 1 . Of the patients who did not return at 8 weeks after the starting cycle corresponding for follow-up and were considered dropouts, to the scheduled day for starting cycle 2 was 13 patients were judged to be cured based negative, and clinical examination also showed on telephone interviews or examination 2 years improvement. Nevertheless, these patients requested or later when they visited our clinic for that another cycle of treatment be prescribed. another disorder. Therefore, most of the 8 If all these patients were judged as being dropout patients, in fact, likely were cured of cured after 1 cycle, two cycles of treatment tinea pedis. If we exclude the 8 dropout were required for a cure in 22 patients with patients, the cure rate was 93.8% and the the plantar type, 6 patients with interdigital type and 10 patients with mixed type. The discontinued in 1 patient because of abdominal majority of patients responded after 1 cycle of pain. In the unevaluable patient, T. rubrum was treatment. Surprisingly, fungal elements of cultured at the initial evaluation, but Candida dermatophytes were detected in plantar callosity was found at the same site 2 months later. of six patients, but KOH examination was Because of the microbial substitution, rating this negative after 1 cycle of treatment. In 1 patient, patient as cured may have been appropriate, there was a relapse during the following year; but clinical examination showed no change, so there were no relapses in the other patients. only the interdigital type. In another patient Barnetson et al. 2 compared 1 week of oral TBF with both the plantar and interdigital type, 250 mg/day with 4 weeks of topical clotrimazole. there was recurrence only on the interdigital region. This suggests that interdigital tinea therapy in both groups were approximately pedis may be more refractory to treatment than 72% and not significantly different. After 16 plantar tinea pedis. Furthermore, over a 3-year weeks with clotrimazole cream there was still period, the relapse rate for the interdigital type no significant difference, but the cure rate was 29.8% was higher than for the plantar type only 54.9% in the TBF group. In our study, if 15.2% . Of the 8 patients with no cure 3 we assume treatment was completed after 1 patients stopped coming to the clinic, so their week of therapy, the cure rate for both plantar clinical course is unknown. One patient continued type and interdigital type tinea pedis was 66.2% topical therapy but had repeated infections. In 114 of 172 cases . This is not considerably 4 patients, continuous treatment with TBF 125 different from the rate reported by Barnetson mg/day was prescribed. Two patients had a et al. 2 In another study of oral TBF in tinea cure with 1 month of treatment, but the other pedis, Hay et al. 3 compared 2 weeks of oral 2 patients had no response to therapy. With TBF 250 mg/day with 4 weeks of oral itraconazole continuous oral TBF 250 mg/day , a cure was 100 mg/day . After 16 weeks, the cure rate judged after 5 weeks and after 8 weeks.
with TBF was 78%. Keyser et al. 4 treated 184 between the patient and physician regarding a weeks and reported a clinical cure rate of relapse; preference was given to the opinion of 94.1% and microbiological cure rate of 88.6% the physician. Although patients who had a after 2 months. Using a similar regimen, White relapse often came back to the clinic, there et al. 5 treated patients with tinea pedis and were relatively few who returned every year tinea manuum and reported microbiological merely to show whether or not they had has a cure rates of 64% after 4 weeks and 86% after relapse. Therefore, we had to evaluate these 8 weeks. The results in our study are similar to patients by phone or e-mail interview. Of thoses 㪈㩷㫐㪼㪸㫉㩷㩿㫅㪔㪈㪈㪌㪀 㪉㩷㫐㪼㪸㫉㫊㩷㩿㫅㪔㪈㪇㪈㪀 㪊㩷㫐㪼㪸㫉㫊㩷㩿㫅㪔㪏㪐㪀 Fig. 1. Relapse rates over the 3-year period after cure The figure depicts results in 115 patients who were followed for at least 3 years after cure.
evaluated by phone or e-mail, about 90% said relatively low compared to topical therapy. they had no relapse and 10% said they had Although health insurance coverage may be a had a relapse. However, of the patients evaluated problem, the fact that many patients only at a clinic visit, about one half had no require 2 or 3 clinic visits means a savings in costs. This, combined with the very low relapse The number of patients lost to follow-up rates, makes oral TBF, in our opinion, the best increased each year and reached more than treatment of choice for many patients with half the cases by 4 years after treatment. This tinea pedis. However, misdiagnosis may be a would not be statistically meaningful, so we potential problem. Accurate diagnosis at the decided to evaluate the presence or absence of initial evaluation should preferably include relapse in patients followed for 3 years or fungal cultures, or at a minimum, the presence longer, which included at least 100 patients. of fungal elements on direct KOH examination. Although the number lost to follow-up increased The issue of recurrence versus reinfection each year, we found that over a 3-year period, must always be considered in patients with approximately 85% of patients had no relapse relapse 1. Our findings of an approximately 10% and approximately 10% of patients had a relapse relapse rate each year over a 3-year period suggest that reinfection is more likely than recurrence.
Topical therapy has been regarded as relatively References
ineffective for hyperkeratotic tinea pedis 6 , but a fungus negative conversion rate of 80.6% for 1 Kagawa S: Prognosis in tinea pedis. Jpn J Med lesions with some degree of keratinization has Mycol 9: 109 114, 1968.
also been reported 7 . This is not substantially different from our results, but few reports have Brookman S, Cowen P, Ellis D and Williams T: addressed the issue of relapse after topical Comparison of one week of oral terbinafine 250 mg/day with four weeks of treatment with therapy. In 380 patients with tinea pedis who clotrimazole 1% cream in interdigital tinea pedis. Brit J Dermatol 139: 675 678, 1998.
Nishimoto 8 reported a cure in only 27 cases. 3 Hay RJ, McGregor JM, Wuite J, Ryatt KS, In that study, the principal clinical problem was Ziegler C, Clayton YM: A comparison of 2 that despite treatment for several to over 10 weeks of terbinafine 250 mg/day with 4 weeks years, many patients still had recurrent relapses. of itraconazole 100 mg/day in plantar-type tinea In addition, several studies following patients pedis. Brit J Dermatol 132: 604 608, 1995.
after cure for at least 1 year found relapse 4 Keyser P De, Backer M De, Massart DL, rates of approximately 50% at 1 year and Westelinck KJ: Two-week oral treatment of tinea thereafter 9 11 . In our study, the relapse rates of pedis, comparing terbinafine 250 mg/day with approximately 10% each year with oral TBF are multicentre study. Brit J Dermatol 130 Suppl.
9 Elewski BE, Bergstresser PR, Hanifin J, Lesher 5 White JE, Perkins PJ and Evans EGV: Successful J, Savin R, Shupack J, Stiller M, Tschen E, 2-week treatment with terbinafine Lamisil for moccasin tinea pedis and tinea manuum. outcome of patients with interdigital tinea Brit J Dermatol, 125: 260 262, 1991.
pedis treated with terbinafine or clotrimazole. 6 Takahashi S: Topical therapy in tinea pedis- J Am Acad Dermatol 32: 290 292, 1995.
Indications for topical therapy and clinical 10 Watanabe S, Takahashi H: Clinical evaluation of significance of steroid-containing antifungal preparations. Jpn J Med Mycol 9: 94 98, 1968.
pedis - Usefulness and relapse rates. The Nishi- 7 Bifonazole Research Group: Evaluation of nihon Journal of Dermatology 59: 293 298,
efficacy and safety of lanoconazole cream in hyperkeratotic tinea pedis. The Nishinihon 11 Naka W: Prevention of recurrent tinea Effective- Journal of Dermatology 55: 961 971, 1993.
ness of long-term topical application of anti- 8 Nishimoto K: Problems in the treatment of tinea fungal drugs after initial treatment. Medical pedis patients. Jpn J Med Mycol 35: 335 339,
Tribune 11: 18 19, December 1997.

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