今日の臨床サポート

足白癬

著者: 常深祐一郎 埼玉医科大学 皮膚科

監修: 戸倉新樹 掛川市・袋井市病院企業団立 中東遠総合医療センター 参与/浜松医科大学 名誉教授

著者校正/監修レビュー済:2020/03/26
参考ガイドライン:
  1. 日本皮膚科学会:皮膚真菌症診療ガイドライン2019
患者向け説明資料

概要・推奨   

  1. 足白癬の診断には鏡検を強く推奨する(推奨度1)
  1. 足白癬に対して抗真菌薬外用は強く推奨される。きちんと治療すれば、90%ほどの治癒率が見込まれる(推奨度1)
  1. 抗真菌薬外用のみでは難治な足白癬に対しては、副作用に注意しながら経口抗真菌薬の投与を行ってもよいが、足白癬全例には推奨できない(推奨度2)
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要と
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要とな
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要とな
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要となりま
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必
薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、
著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適用の査定において保険適用及び保険適用外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適用の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
常深祐一郎 : 講演料(エーザイ株式会社,科研製薬,佐藤製薬,鳥居薬品,マルホ)[2021年]
監修:戸倉新樹 : 講演料(田辺三菱,サノフィ,マルホ,協和キリン),研究費・助成金など(ノバルティス,レオファーマ)[2021年]

改訂のポイント:
  1. 日本皮膚科学会の皮膚真菌症診療ガイドライン2019に基づき、主に経口抗真菌薬について加筆修正を行った。

病態・疫学・診察

疾患情報(疫学・病態)  
  1. 足白癬とは、白癬菌が趾間や足底に感染することにより、趾間や足底に鱗屑、水疱、浸軟、角化などの症状が生じることである。疫学調査によると、日本では人口の約20%が足白癬に罹患。非常に頻度の高い疾患である。
  1. 「水虫」として有名なため、患者は足にできる病変は何でも水虫とみなす傾向がある。
  1. 市販薬も多いため、医療機関を受診せず、自己判断で治療している患者が多い。
  1. 足白癬と臨床像が似た疾患は多く、自己治療している患者が本当に足白癬であるとは限らない。
  1. 医療機関を受診しても、鏡検を行わず臨床所見のみで足白癬と診断され、治療を開始されている例が多い。が、実際には足白癬でないこともあり、当然、改善しない。
  1. 足白癬であっても十分な治療を行わず、再発を繰り返す患者もまれではない。
病歴・診察のポイント  
  1. 趾間や足底に鱗屑、水疱、浸軟、角化などの症状が生じる。

これより先の閲覧には個人契約のトライアルまたはお申込みが必要です。

最新のエビデンスに基づいた二次文献データベース「今日の臨床サポート」。
常時アップデートされており、最新のエビデンスを各分野のエキスパートが豊富な図表や処方・検査例を交えて分かりやすく解説。日常臨床で遭遇するほぼ全ての症状・疾患から薬剤・検査情報まで瞬時に検索可能です。

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文献 

著者: L A Drake, S M Dinehart, E R Farmer, R W Goltz, G F Graham, M K Hardinsky, C W Lewis, D M Pariser, J W Skouge, S B Webster, D C Whitaker, B Butler, B J Lowery, B E Elewski, M L Elgart, P H Jacobs, J L Lesher, R K Scher
雑誌名: J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):282-6.
Abstract/Text
PMID 8642094  J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):282-6.
著者: Jacob Oren Levitt, Barrie H Levitt, Arash Akhavan, Howard Yanofsky
雑誌名: Dermatol Res Pract. 2010;2010:764843. doi: 10.1155/2010/764843. Epub 2010 Jun 22.
Abstract/Text Background. There are relatively few studies published examining the sensitivity and specificity of potassium hydroxide (KOH) smear and fungal culture examination of tinea pedis. Objective. To evaluate the sensitivity and specificity of KOH smear and fungal culture for diagnosing tinea pedis. Methods. A pooled analysis of data from five similarly conducted bioequivalence trials for antifungal drugs was performed. Data from 460 patients enrolled in the vehicle arms of these studies with clinical diagnosis of tinea pedis supported by positive fungal culture were analyzed 6 weeks after initiation of the study to determine the sensitivity and specificity of KOH smear and fungal culture. Results. Using clinical assessment as the gold standard, the sensitivities for KOH smear and culture were 73.3% (95% CI: 66.3 to 79.5%) and 41.7% (34.6 to 49.1%), respectively. The respective specificities for culture and KOH smear were 77.7% (72.2 to 82.5%) and 42.5% (36.6 to 48.6%). Conclusion. KOH smear and fungal culture are complementary diagnostic tests for tinea pedis, with the former being the more sensitive test of the two, and the latter being more specific.

PMID 20672004  Dermatol Res Pract. 2010;2010:764843. doi: 10.1155/2010・・・
著者: H Noguchi, M Hiruma, A Kawada, A Ishibashi, S Kono
雑誌名: Mycoses. 1995 Nov-Dec;38(11-12):494-9.
Abstract/Text We examined the relationship between prevalence and severity of tinea pedis and the length of service and the width of the spaces between the toes in 74 members of the Japanese Self-Defence Forces (SDF) undergoing special training. The subjects were divided according to the width of these spaces into: group I, wide; group II, fairly wide; and group III, closed. The severity of tinea pedis was determined by its duration and the extent of the lesions in the 49 subjects who had tinea pedis. The combined prevalence of tinea pedis and tinea unguium was 66%. There was a tendency for the prevalence to be higher in subjects who had served for 10 years or more in the SDF than in those with fewer than 10 years of service. Classified by the disposition of their toes, 10 subjects fell into group I, 34 into group II, and 30 into group III. The prevalence of 90% (27/30) in group III was significantly higher than in the other groups. A significant positive correlation was seen between length of SDF service and severity. Subjects with both a long service record and closed interdigital spaces showed both a high prevalence and marked severity.

PMID 8720203  Mycoses. 1995 Nov-Dec;38(11-12):494-9.
著者: F Crawford, S Hollis
雑誌名: Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001434. doi: 10.1002/14651858.CD001434.pub2. Epub 2007 Jul 18.
Abstract/Text BACKGROUND: Fungal infections of the feet normally occur in the outermost layer of the skin (epidermis). The skin between the toes is a frequent site of infection which can cause pain and itchiness. Fungal infections of the nail (onychomycosis) can affect the entire nail plate.
OBJECTIVES: To assess the effects of topical treatments in successfully treating (rate of treatment failure) fungal infections of the skin of the feet and toenails and in preventing recurrence.
SEARCH STRATEGY: We searched the Cochrane Skin Group Specialised Register (January 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005), MEDLINE and EMBASE (from inception to January 2005). We screened the Science Citation Index, BIOSIS, CAB - Health and Healthstar, CINAHL DARE, NHS Economic Evaluation Database and EconLit (March 2005). Bibliographies were searched.
SELECTION CRITERIA: Randomised controlled trials (RCTs) using participants who had mycologically diagnosed fungal infections of the skin and nails of the foot.
DATA COLLECTION AND ANALYSIS: Two authors independently summarised the included trials and appraised their quality of reporting using a structured data extraction tool.
MAIN RESULTS: Of the 144 identified papers, 67 trials met the inclusion criteria. Placebo-controlled trials yielded the following pooled risk ratios (RR) of treatment failure for skin infections: allylamines RR 0.33 (95% CI 0.24 to 0.44); azoles RR 0.30 (95% CI 0.20 to 0.45); ciclopiroxolamine RR 0.27 (95% CI 0.11 to 0.66); tolnaftate RR 0.19 (95% CI 0.08 to 0.44); butenafine RR 0.33 (95% CI 0.24 to 0.45); undecanoates RR 0.29 (95% CI 0.12 - 0.70). Meta-analysis of 11 trials comparing allylamines and azoles showed a risk ratio of treatment failure RR 0.63 (95% CI 0.42 to 0.94) in favour of allylamines. Evidence for the management of topical treatments for infections of the toenails is sparser. There is some evidence that ciclopiroxolamine and butenafine are both effective but they both need to be applied daily for prolonged periods (at least 1 year). The 6 trials of nail infections provided evidence that topical ciclopiroxolamine has poor cure rates and that amorolfine might be substantially more effective but more research is required.
AUTHORS' CONCLUSIONS: Placebo-controlled trials of allylamines and azoles for athlete's foot consistently produce much higher percentages of cure than placebo. Allylamines cure slightly more infections than azoles and are now available OTC. Further research into the effectiveness of antifungal agents for nail infections is required.

PMID 17636672  Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001434. d・・・
著者: H C Korting, H J Tietz, M Bräutigam, P Mayser, G Rapatz, C Paul
雑誌名: Med Mycol. 2001 Aug;39(4):335-40.
Abstract/Text Duration of therapy is an important factor determining patients' compliance in dermatomycosis clinical practice. We undertook a prospective, randomised, double-blind, parallel group study to investigate the efficacy and tolerability of once daily treatment with terbinafine 1% cream for 1 week, compared to its vehicle, in adult patients with interdigital tinea pedis. Efficacy was assessed in terms of mycological cure, total clinical signs and symptoms scores, and clinical response, 1 day and 1, 5 and 7 weeks after end of treatment. Terbinafine 1% cream was significantly more effective than its vehicle in achieving and maintaining mycological cure for 7 weeks: 91.4% vs. 37.1%, P < 0.001. Terbinafine was also significantly more effective than its vehicle in reducing total clinical signs and symptoms scores, and in achieving clinical response. We conclude that terbinafine 1% cream, applied once daily for 7 days, is an effective and well-tolerated treatment for interdigital tinea pedis in nonimmunocompromised patients. The short duration of treatment needed to achieve mycological cure has important implications for patient compliance and for control of infection within the community.

PMID 11556763  Med Mycol. 2001 Aug;39(4):335-40.
著者: Sally E M Bell-Syer, Sameena M Khan, David J Torgerson
雑誌名: Cochrane Database Syst Rev. 2012 Oct 17;10:CD003584. doi: 10.1002/14651858.CD003584.pub2. Epub 2012 Oct 17.
Abstract/Text BACKGROUND: About 15% of the world population have fungal infections of the feet (tinea pedis or athlete's foot). There are many clinical presentations of tinea pedis, and most commonly, tinea pedis is seen between the toes (interdigital) and on the soles, heels, and sides of the foot (plantar). Plantar tinea pedis is known as moccasin foot. Once acquired, the infection can spread to other sites including the nails, which can be a source of re-infection. Oral therapy is usually used for chronic conditions or when topical treatment has failed.
OBJECTIVES: To assess the effects of oral treatments for fungal infections of the skin of the foot (tinea pedis).
SEARCH METHODS: For this update we searched the following databases to July 2012: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, MEDLINE (from 1946), EMBASE (from 1974), and CINAHL (from 1981). We checked the bibliographies of retrieved trials for further references to relevant trials, and we searched online trials registers.
SELECTION CRITERIA: Randomised controlled trials of oral treatments in participants who have a clinically diagnosed tinea pedis, confirmed by microscopy and growth of dermatophytes (fungi) in culture.
DATA COLLECTION AND ANALYSIS: Two review authors independently undertook study selection, 'Risk of bias' assessment, and data extraction.
MAIN RESULTS: We included 15 trials, involving 1438 participants. The 2 trials (71 participants) comparing terbinafine and griseofulvin produced a pooled risk ratio (RR) of 2.26 (95% confidence interval (CI) 1.49 to 3.44) in favour of terbinafine's ability to cure infection. No significant difference was detected between terbinafine and itraconazole, fluconazole and itraconazole, fluconazole and ketoconazole, or between griseofulvin and ketoconazole, although the trials were generally small. Two trials showed that terbinafine and itraconazole were effective compared with placebo: terbinafine (31 participants, RR 24.54, 95% CI 1.57 to 384.32) and itraconazole (72 participants, RR 6.67, 95% CI 2.17 to 20.48). All drugs reported adverse effects, with gastrointestinal effects most commonly reported. Ten of the trials were published over 15 years ago, and this is reflected by the poor reporting of information from which to make a clear 'Risk of bias' assessment. Only one trial was at low risk of bias overall. The majority of the remaining trials were judged as 'unclear' risk of bias because of the lack of clear statements with respect to methods of generating the randomisation sequence and allocation concealment. More trials achieved blinding of participants and personnel than blinding of the outcome assessors, which was again poorly reported.
AUTHORS' CONCLUSIONS: The evidence suggests that terbinafine is more effective than griseofulvin, and terbinafine and itraconazole are more effective than no treatment. In order to produce more reliable data, a rigorous evaluation of different drug therapies needs to be undertaken with larger sample sizes to ensure they are large enough to show any real difference when two treatments are being compared. It is also important to continue to follow up and collect data, preferably for six months after the end of the intervention period, to establish whether or not the infection recurred.

PMID 23076898  Cochrane Database Syst Rev. 2012 Oct 17;10:CD003584. do・・・
著者: E Svejgaard, C Avnstorp, B Wanscher, J Nilsson, A Heremans
雑誌名: Dermatology. 1998;197(4):368-72.
Abstract/Text BACKGROUND: Treatment of plantar or moccasin-type tinea pedis with conventional oral antifungal agents produces poor response rates. Itraconazole is a synthetic, broad-spectrum, orally active antifungal agent with pronounced antimycotic activity.
OBJECTIVE: To confirm the efficacy and safety of short-term treatment with itraconazole for plantar or moccasin-type tinea pedis.
METHODS: The study was a double-blind, randomized, placebo-controlled, multicenter trial. Seventy-two patients with tinea pedis (plantar or moccasin-type) were treated with itraconazole (200 mg twice daily) or placebo for 1 week with an 8-week treatment-free follow-up period.
RESULTS: Thirty-six patients were randomized to each treatment group. The overall success rate (mycological cure and clinical response) at the end-point of follow-up was significantly higher in the itraconazole group than in the placebo group (53 vs. 3%; p <0. 001). Mycological cure (56 vs. 8%; p <0.001) and clinical response rates (75 vs. 11%; p <0.001) were significantly higher after itraconazole treatment compared with placebo treatment. During treatment, adverse events were recorded in 7 patients in the itraconazole group and 2 patients in the placebo group. Adverse events were noted in 3 patients in the placebo group during follow-up. No serious adverse events were reported in either group.
CONCLUSIONS: Short-term treatment with itraconazole was significantly more effective than placebo in tinea pedis. The safety and tolerability profile or itraconazole was comparable with placebo.

PMID 9873176  Dermatology. 1998;197(4):368-72.
著者: R C Savin, N Zaias
雑誌名: J Am Acad Dermatol. 1990 Oct;23(4 Pt 2):804-7.
Abstract/Text Terbinafine is an orally and topically active fungicidal drug of the allylamine series. Its oral efficacy at 125 mg taken twice daily was evaluated in a randomized, double-blind, placebo-controlled study in moccasin-type tinea pedis. The study was conducted simultaneously in two centers and consisted of 41 evaluable cases (23 terbinafine, 18 placebo). Mycologic cure and near to complete clearing of signs and symptoms were obtained in 59% of the terbinafine-treated patients after 6 weeks of treatment and in 65% at 2 weeks after treatment. Corresponding efficacy for placebo-treated patients was zero at both evaluations. Side effects in both groups were minimal. We conclude that terbinafine is well tolerated and highly effective in moccasin-type tinea pedis.

PMID 2229528  J Am Acad Dermatol. 1990 Oct;23(4 Pt 2):804-7.
著者: I Tausch, J Decroix, Z Gwiezdzinski, S Urbanowski, E Baran, M Ziarkiewicz, G Levy, A Del Palacio
雑誌名: Int J Dermatol. 1998 Feb;37(2):140-2.
Abstract/Text A total of 304 patients with a clinical diagnosis of palmar-type tinea pedis or manus and a positive mycologic examination were recruited into this double-blind, randomized, multicenter, phase III study. Patients were randomized to receive either oral itraconazole 200 mg twice daily (in the morning and evening) for 7 days, followed by placebo for 7 days (n = 153), or placebo in the morning and oral terbinafine 250 mg in the evening for 14 days (n = 151). At the first visit and 1, 2, and 6 weeks after the start of the study, signs and symptoms were assessed clinically, and scales were taken for mycologic assessments (microscopy and culture). At weeks 1, 2, and 6, the effectiveness of therapy was evaluated globally and given a rating of healed (absence of signs and symptoms), marked improvement (> or = 50% clinical improvement), considerable residual lesions (< 50% clinical improvement), no change, or worsened. The primary efficacy parameter was the mycologic cure rate at the follow-up end-point (week 6). The tolerability of the study medications was assessed at weeks 1 and 2. Adverse events were recorded at weeks 1, 2, and 6. Routine hematologic and biochemical tests were performed at the start of the study and after 1 week of treatment. No significant differences were seen in the baseline patient characteristics between the two groups. The rate of mycologic cure (negative microscopy and culture test result) was 79% in the itraconazole group and 80% in the terbinafine group at the follow-up end-point. The analysis of the 90% confidence interval for the difference between the treatment groups (-7.1, 5.4) and the outcome of the Blackwelder test (for two one-sided tests, P = 0.013 and P = 0.029) showed the two treatments to be equivalent. The results of the global evaluations of the efficacy in the two treatment groups are shown in Table 1. The rate of clinical response (healed or markedly improved) was 93% in the itraconazole group and 91% in the terbinafine group at the follow-up end-point. The analysis of the 90% confidence interval for the difference between the two groups (-2.5, 5.7) and the outcome of the Blackwelder test (for two one-sided tests, P = 0.004 and P < 0.001) showed the two treatments to be equivalent. The severity of the clinical signs and symptoms decreased from the baseline to the treatment end-point and from the treatment end-point to the follow-up end-point in both groups. At the double-blind treatment period end-point (week 2), the tolerability of the study medication was rated as very good or good in more than 97% of patients. During treatment, 21 of 153 patients (14%) in the itraconazole group and 28 of 151 patients (19%) in the terbinafine group reported adverse events. During follow-up, one patient in the itraconazole group and two in the terbinafine group reported adverse events. The most frequent events were headache, abdominal pain, nausea, vomiting, and hypertriglyceridemia. Two patients in the itraconazole group and four in the terbinafine group withdrew because of adverse events. Severe adverse events were reported by one patient in the itraconazole group and five in the terbinafine group. Serious adverse events were reported by two patients in the terbinafine group, although these were probably not drug related. No clinically relevant changes in laboratory variables were observed.

PMID 9542675  Int J Dermatol. 1998 Feb;37(2):140-2.
著者: N Zaias, F Battistini, F Gomez-Urcuyo, R F Rojas, R Ricart
雑誌名: Cutis. 1978 Aug;22(2):197-9.
Abstract/Text A protocol for determining the antifungal efficacy of systemic or topical drugs in tinea pedis is presented. In this study, (1) no patient had concomitant onychomycosis; (2) the clinical types were separated into (a) plantar scaling, (b) intertriginous, and (c) vesicular instep; (3) the soles were treated for three months (time related to the shedding of all stratum corneum); (4) the follow-up period for soles was three months (related to characteristics of the drug and its depot effect on the target area, the horny layer); (5) the final evaluation related to the percentage of patients "clinically and mycologically cured" at the end of the follow-up period. With this protocol, ultramicrosize griseofulvin (Gris-PEG) alone, topical clotrimazole (Lotrimin) alone, and a combination of the two were tested in seventy-three patients with tinea pedis. The results were as follows: for plantar scaling type of tinea pedis, the combination was not better than griseofulvin alone; for intertriginous tinea pedis, the combination was definitely better than griseofulvin alone; and topical 1 percent clotrimazole was much less effective than griseofulvin.

PMID 688767  Cutis. 1978 Aug;22(2):197-9.
著者: H Tanuma, M Tanuma, M Abe, H Kume
雑誌名: Mycoses. 2001;44(5):181-90.
Abstract/Text Hyperkeratotic type tinea pedis is a refractory type of superficial dermatomycosis. Treatment for hyperkeratotic type tinea pedis is mainly with oral antimycotics, such as griseofulvin, and healing is generally considered to be difficult with only topical antimycotics. In this randomized comparative study, the usefulness of a topical application of 1% lanoconazole cream (Astat) monotherapy (group I) was compared with that of combination therapy with 1% lanoconazole cream and 10% urea ointment (Pastaron) (group II) in a series of patients with hyperkeratotic type tinea pedis. The clinical improvement rates (percentage of 'marked improvement' plus 'moderate improvement') was 70.0% in group I and 95.7% in group II. The fungal eradication rate was 5.0% in group I and 43.5% in group II after 4 weeks of treatment, and was 70.0% and 95.7% after 12 weeks of treatment, respectively. The usefulness rate (percentage of 'very useful' plus 'useful') was 70% in group I and 95.7% in group II. Both lanoconazole monotherapy and the combination therapy with 10% urea ointment were highly effective and safe. Both treatments should be recommended for patients with hyperkeratotic type tinea pedis for whom an oral treatment is not appropriate or for whom a sufficient improvement with oral medications cannot be expected.

PMID 11486456  Mycoses. 2001;44(5):181-90.
著者: A Alomar, S Videla, J Delgadillo, I Gich, I Izquierdo, J Forn
雑誌名: Dermatology. 1995;190(4):295-300.
Abstract/Text BACKGROUND: Flutrimazole is a new imidazole derivate. Its antifungal activity has been demonstrated in in vivo and in vitro studies to be comparable to that of clotrimazole and higher than bifonazole.
AIM: To compare the efficacy and tolerability of flutrimazole cream 1% with a reference drug, bifonazole, in the treatment of dermatomycoses, eligible for topical treatment exclusively.
METHODS: A multicentre, double-blind, randomized, parallel-group clinical trial was conducted. Patients with clinically and mycologically (KHO and/or culture) diagnosed fungal infection of the skin were included in this study and were randomized into two treatment groups: 1% flutrimazole or 1% bifonazole, applied to the affected area (target lesion) once a day. The principal criterion of efficacy, 'cure', was based on clinical and mycological assessment.
RESULTS: Four hundred and forty-nine patients were included in the study (228 flutrimazole, 221 bifonazole). 'Intention-to-treat' analysis of the data showed a difference between the treatments in terms of the rate of cure (clinical and mycological) after 4 weeks: 73% in the flutrimazole group and 65% in the bifonazole group (p = 0.05). From a safety point of view, flutrimazole and bifonazole were well tolerated, and the overall incidence of adverse effects (mainly mild local effects like irritation or burning sensation) was 5%.
CONCLUSIONS: One percent flutrimazole applied topically once a day in the treatment of fungal infections of the skin presents a better efficacy than bifonazole and a good tolerability.

PMID 7655109  Dermatology. 1995;190(4):295-300.
著者: M V Shelanski, S B Phillips, C E Potts
雑誌名: Int J Dermatol. 1996 Feb;35(2):137-40.
Abstract/Text BACKGROUND: Reports of purported sensitization reactions to widely used prescription dermatologicals have raised questions concerning the clinical significance of these reports. The current study was designed to compare irritant and sensitization potentials of such marketed products and to evaluate the risks involved in their usage.
METHODS: One hundred and eight healthy adult volunteers were evaluated for primary irritation and hypersensitivity following application under a double-blind paradigm of eight leading prescription dermatologic products and the vehicle cream of one product according to an intensified version of the Shelanski and Shelanski "Repeated Insult Patch Test."
RESULTS: No clinically significant irritant or sensitization reactions were associated with applications of topical formulations containing clobetasol propionate, doxepin hydrochloride, metronidazole, mupirocin, oxiconazole nitrate, and terbinafine hydrochloride. The doxepin hydrochloride cream vehicle was also found to be nonirritating and nonsensitizing. Both calcipotriene and ketoconazole were moderate irritants and possible sensitization reactions were also associated with ketoconazole.
CONCLUSION: Although every topically applied chemical has the potential to cause an adverse response in some individuals, the data obtained in this study for eight commercially available prescription dermatologic products indicate that most are quite safe and have very low risks of clinically significant irritation or sensitization.

PMID 8850048  Int J Dermatol. 1996 Feb;35(2):137-40.
著者: R B Odom, R Aly, R K Scher, C R Daniel, B E Elewski, N Zaias, R DeVillez, M Jacko, N Oleka, B L Moskovitz
雑誌名: J Am Acad Dermatol. 1997 Feb;36(2 Pt 1):231-5.
Abstract/Text BACKGROUND: Onychomycosis is the most frequent cause of nail disease and represents 30% of all mycotic infections of the skin.
OBJECTIVE: Our purpose was to compare the effectiveness and tolerability of intermittent dosing of itraconazole ("pulse therapy") with placebo in fingernail onychomycosis.
METHODS: Seventy-three patients with clinically and mycologically diagnosed fingernail onychomycosis were randomly selected to receive itraconazole, 200 mg twice daily, or placebo for the first week of each month for 2 consecutive months; patients were observed for 19 weeks. Seventy-one patients received the study medication and were included in the safety analysis. Efficacy of treatment was evaluated in 46 patients.
RESULTS: A significantly greater proportion of itraconazole-treated patients than placebo-treated patients achieved clinical success (77% vs 0%), mycologic success (73% vs 13%), and overall success (68% vs 0%). No itraconazole-treated patient had a clinical or mycologic relapse during the follow-up period. Ten itraconazole-treated patients (28%) and nine placebo-treated patients (26%) had adverse events. Three patients discontinued treatment for safety reasons.
CONCLUSION: Pulse therapy with itraconazole for 2 consecutive months produces significantly greater clinical, mycologic, and overall success than placebo. Short-term itraconazole pulse therapy for fingernail onychomycosis is effective and well tolerated.

PMID 9039174  J Am Acad Dermatol. 1997 Feb;36(2 Pt 1):231-5.
著者: L A Drake, N H Shear, J P Arlette, R Cloutier, F W Danby, B E Elewski, S Garnis-Jones, J M Giroux, D Gratton, W Gulliver, P Hull, H E Jones, M Journet, A L Krol, J J Leyden, S C Maddin, J B Ross, R C Savin, R K Scher, G R Sibbald, N H Tawfik, N Zaias, M Tolpin, S Evans, J E Birnbaum
雑誌名: J Am Acad Dermatol. 1997 Nov;37(5 Pt 1):740-5.
Abstract/Text BACKGROUND: Onychomycosis is an increasing problem with limited therapeutic options.
OBJECTIVE: We evaluated the safety and efficacy, of oral terbinafine, a new fungicidal antimycotic, in patients with toenail onychomycosis.
METHODS: A North American multicenter, double-blind, placebo-controlled study evaluated the mycologic and clinical efficacy of oral terbinafine 250 mg/day for 12 or 24 weeks in 358 patients with toenail onychomycosis.
RESULTS: A total of 74% of patients treated with 12 or 24 weeks of terbinafine achieved a successful clinical outcome. Approximately 11% of terbinafine responders showed evidence of relapse 18 of 21 months after cessation of treatment. Terbinafine was well tolerated; most adverse events were transient and mild to moderate in severity.
CONCLUSION: The results of this study confirm that oral terbinafine is a safe and effective therapy for the treatment of onychomycosis.

PMID 9366820  J Am Acad Dermatol. 1997 Nov;37(5 Pt 1):740-5.
著者: Shinichi Watanabe, Ichiro Tsubouchi, Akihiro Okubo
雑誌名: J Dermatol. 2018 Oct;45(10):1151-1159. doi: 10.1111/1346-8138.14607. Epub 2018 Aug 29.
Abstract/Text Fosravuconazole L-lysine ethanolate (F-RVCZ) is a prodrug of ravuconazole, a novel triazole antifungal agent, exerting broad and potent antifungal activity. The efficacy and safety of F-RVCZ, compared with a placebo, were investigated in a multicenter, double-blind, randomized study of Japanese onychomycosis patients with 25% or more clinical involvement of the target toenail. Subjects (n = 153) were randomly assigned to receive F-RVCZ (100 mg RVCZ, n = 101) or placebo (n = 52) p.o. once daily for 12 weeks. The primary end-point was the rate of complete cure (clinical cure [0% clinical involvement of the target toenail] plus mycological cure [negative potassium hydroxide examination]) at week 48 (36-week post-treatment visit). Secondary end-points were changes over time in the efficacy and mycological effect of F-RVCZ. Safety was also evaluated. The complete cure rate at week 48 was significantly higher with F-RVCZ (59.4%, 60/101) than the placebo (5.8%, 3/52) in the full analysis set (P < 0.001). The mycological cure rate at week 48 was also significantly higher with F-RVCZ (82.0%, 73/89) than the placebo (20.0%, 10/50, P < 0.001). Regarding safety, adverse events were observed in 83.2% (84/101) and 80.8% (42/52), and adverse drug reactions (ADR) in 23.8% (24/101) and 3.8% (2/52) of F-RVCZ and placebo subjects, respectively. ADR were mild to moderate in severity, with none being serious. F-RVCZ (equivalent to 100 mg ravuconazole) administrated once daily for 12 weeks was more effective than placebo and tolerable in patients with onychomycosis, suggesting it to be a promising drug for onychomycosis treatment.

© 2018 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.
PMID 30156314  J Dermatol. 2018 Oct;45(10):1151-1159. doi: 10.1111/134・・・
著者: G Albanese, R Di Cintio, P Giorgetti, G Galbiati, M Ciampini
雑誌名: Mycoses. 1992 May-Jun;35(5-6):157-9.
Abstract/Text Tinea pedis is a common and frequently recurring dermatophytic infection, which is extremely difficult to eradicate. The often inevitable persistence of predisposing conditions, especially maceration, suggests that application of powders containing antifungal medication to the affected area could be effective in preventive therapy against recurrence. For this study we used one of the most recent azole antifungal agents, fenticonazole. Thirty patients affected with tinea pedis were cured with topical antifungal treatment; both the diagnosis and the cure were confirmed by microscopic and cultural mycological analyses. The results of subsequent double blind antifungal versus placebo treatment (controlled with clinical and mycological tests over a period of 4 months and with a final statistic evaluation) confirmed the effectiveness of such therapy in reducing the frequency of tiresome relapses in such patients.

PMID 1474987  Mycoses. 1992 May-Jun;35(5-6):157-9.
著者: R L Galimberti, L Belli, R Negroni, J M Castro, R Rohwedder, M A Tuculet
雑誌名: Dermatologica. 1984;169 Suppl 1:111-6.
Abstract/Text With the objectives of determining the effectiveness of bifonazole 1% powder in the prophylactic treatment of tinea pedis interdigitalis and its local tolerance, 200 patients who achieved clinical and mycological cure in another previous trial with bifonazole 1% gel, and who were also reliable in the compliance of the treatment, were included in this study. Informed consent was requested and obtained in each case. This was a multicenter, double-blind, controlled and comparative study of one group (100 patients) treated with bifonazole verum against another group (100 patients) treated with bifonazole placebo. The allocation to each group was performed by randomization. Bifonazole was applied once daily in the morning on both feet, after showering, and inside shoes; patients applied it again when changing shoes or socks during the day. Treatment lasted up to 6 months. During the treatment, patients were clinically and mycologically assessed once a month and, if it was necessary, when signs and/or symptoms of infection reappeared. The evaluation criteria were based on the reinfection, clinically and mycologically demonstrable, during the treatment. 29 patients abandoned the treatment. Reinfection was observed in 57 out of the 171 patients who finished the treatment, 47 reinfections occurred in the placebo group and the remaining 10 in the verum group. Tolerance was excellent, no side effects were observed in any patient.

PMID 6396114  Dermatologica. 1984;169 Suppl 1:111-6.

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