Double-Blind Comparison of Itraconazole with Griseofulvin in the Treatment of Tinea Corporis and Tinea Cruris

Seventy-eight patients with tinea corporis or tinea cruris participated in a double-blind study with either 100 mg itraconazole or 500 mg ultramicronized griseofulvin for 15 consecutive days. Clinical outcome was significantly in favor of itraconazole at completion of treatment (72% response rate vs. 51%) and at the follow-up visit (91% response vs. 64%). The most important difference between both treatments was the mycologic outcome, for which itraconazole showed a cure rate of 87% compared to 57% for griseofulvin 2 weeks after completion of therapy. It is suggested that 100 mg of itraconazole orally once daily is significantly more effective than 500 mg of griseofulvin once daily for 15 days in the treatment of glabrous skin infections. Both drugs were well tolerated.     

Itraconazole in the treatment of tinea corporis and tinea cruris

Forty-five patients with tinea corporis or tinea cruris were treated with oral itraconazole 100 mg daily for 15 days. At the end of the 15-day treatment, 80% of the patients were healed or had markedly improved. At the first follow-up visit, 2 weeks after stopping therapy, 80% of patients were considered responders. An additional follow-up visit another month later (i. e. 6 weeks post-treatment) showed that 32 of 41 patients had responded (78%). Overall, the mycological cure rate (culture and microscopy negative) was somewhat lower than the clinical response rate. Only three patients reported minor side effects (7%). Nausea was reported by two patients and an urticarial reaction was seen in one patient after 8 days treatment. This latter patient discontinued therapy because of the adverse experience. It is concluded that itraconazole, given at a daily dose of 100 mg for 15 days, is effective in the treatment of tinea corporis and tinea cruris. Response rates at the last visit (6 weeks post-therapy) remained at the same satisfactory levels as at the first follow-up visit (2 weeks post-therapy), even though treatment was stopped after 2 weeks. Itraconazole appears to be well tolerated by patients. These results, both in terms of efficacy and side effects, are in line with results reported by other investigators. The fact that the mycological cure rates were somewhat lower than the clinical response rates had apparently no influence on the relapse rate at 6 weeks follow-up post-therapy.     

美克治疗体股癣、手足癣、花斑癣和皮肤念珠菌病疗效观察

目的评价美克(1%联苯苄唑乳膏)治疗体股癣、手足癣、花斑癣和皮肤念珠菌病的临床疗效和安全性。方法采用多中心、随机、平行对照的方法,试验组外用美克,对照组外用欣欣(1%盐酸布替萘芬乳膏)。结果体股癣患者停药时试验组与对照组痊愈率分别为42.20%和39.45%,有效率分别为94.49%和91.74%;停药2w时,试验组与对照组痊愈率分别为85.32%和82.56%,有效率分别为97.24%和96.33%。手足癣停药时试验组与对照组痊愈率分别为39.87%和37.34%,有效率分别为85.54%和84.81%;停药2w时,试验组与对照组痊愈率分别为59.49%和58.22%,有效率分别为89.24%和86.70%。花斑癣患者停药时试验组与对照组痊愈率分别为50.72%和52.17%,有效率分别为79.71%和76.81%;停药2w时,试验组与对照组痊愈率分别为66.67%和63.76%,有效率分别为84.05%和81.16%。皮肤念珠菌病患者停药时试验组与对照组痊愈率分别为34.88%和39.53%,有效率分别为72.09%和76.74%;停药2w时,试验组与对照组痊愈率分别为65.11%和67.44%,有效率分别为88.37%和86.04%。局部不良反应发生率各试验组合计为5.27%;各对照组合计为5.54%。上述各项指标,各病种试验组与对照组比较差异均无统计学意义。结论美克治疗体股癣、手足癣、花斑癣和皮肤念珠菌病安全有效。     

A multicentre (double-blind) comparative study to assess the safety and efficacy of fluconazole and griseofulvin in the treatment of tinea corporis and tinea cruris

In a double-blind, parallel group study we compared fluconazole 150mg once weekly with griseofulvin 500 mg once daily for 4–6 weeks in the treatment of tinea corporis or tinea cruris. Eighty-four of 114 patients (74%) (39% after 3 weeks) were clinically cured in the fluconazole group compared with 72 of 116 (62%) (39% after 3 weeks) in tbe griseofulvin group (P = 0·06). In tbe fluconazole group 78% were mycological cured compared with 80% in the griseofulvin group. In the fluconazole group nine patients (7·5%) had treatment related adverse events and in tbe griseofulvin group 15 patients (12·5%) had adverse events. Fluconazole 150 mg once weekly for 6 weeks is botb clinically and mycologically effective in the treatment of tinea corporis and tinea cruris and few side-effects were reported.     

The use of itraconazole to treat cutaneous fungal infections in children

BACKGROUND: Cutaneous mycoses such as tinea capitis, onychomycosis and some cases of tinea corporis/cruris, and tinea pedis/manus require oral antifungal therapy. There is relatively limited data regarding the use of the newer oral antifungal agents, e.g. itraconazole, in the treatment of these mycoses in children. OBJECTIVE: We wished to determine the efficacy and safety of itraconazole continuous therapy in the management of cutaneous fungal infections in children. METHODS: Children with cutaneous mycoses were treated with itraconazole in an open-label manner in 4 studies. For tinea capitis, the treatment regimens using itraconazole continuous therapy were: study 1, 3 mg/kg/day for 4 or 8 weeks; study 2, 5 mg/kg/day for 6 weeks, and study 3, 5 mg/kg/ day for 4 weeks. In a different trial, study 4, itraconazole continuous therapy 5 mg/kg/day was used to treat toenail onychomycosis (duration: 12 weeks), tinea corporis/ cruris (duration: 1 week) and tinea pedis/manus (duration: 2 weeks). RESULTS: The efficacy rates at follow-up 12 weeks from the start of therapy in children with tinea capitis treated using the itraconazole continuous regimen were: clinical cure (CC) and mycological cure (MC) in study 1 (n = 10, Trichophyton violaceum all patients), CC 50%, MC 86%; in study 2 (n = 35, Microsporum canis 22 patients, Trichophyton sp. 12 patients), CC 82.8%, MC 80%, and in study 3 (n = 16, M. canis 11 patients, Trichophyton sp. 5 patients), (CC 66.7%, MC 78.5%. Itraconazole was also effective in the treatment of dermatomycoses in 24 children (study 4). The CC and MC rates at the follow-up 8 weeks from the start of therapy in children with dermatomycoses and 12 months in children treated for onychomycosis were: onychomycosis (n = 1, T. rubrum), CC 100%, MC 100%; tinea corporis (n = 12, M. canis 10 patients), CC 100%, MC 90%; tinea cruris (n = 3, Trichophyton sp. 2 patients), CC 100%, MC 100%; tinea manus (n = 1, T. rubrum), CC 100%, MC 100%, and tinea pedis (n = 7, T. rubrum), CC 100%, MC 100%). Adverse effects consisted of a cutaneous eruption in 1 (1.2%) of the 85 children, with mild, transient, asymptomatic elevation of liver function tests (less than twice the upper limit of normal) in 2 (3.4%) of 58 children in whom monitoring was performed. CONCLUSIONS: Itraconazole is effective and safe in the treatment of tinea capitis and other cutaneous fungal infections in children.     

A double-blind comparison of itraconazole and fluconazole in tinea pedis and tinea manuum

Background It has been reported that azole derivatives are useful in the treatment of dermatophytoses, also in tinea pedis and tinea manuum. Aim The aim of the present multicentre, randomized, double-blind study was to compare the efficacy and safety of oral itraconazole with fluconazole in the treatment of tinea pedis and tinea manuum. Patients and methods In this multicenter, double-blind, comparative study, 37 patients with tinea pedis or tinea manus were randomized to receive treatment with itraconazole (100 mg/day) or fluconazole (50 mg/day) for 30 days. Results Two patients were not evaluable for efficacy. Both treatments reduced the number of patients with positive mycological findings, so that at the end of treatment. 64.7% of patients receiving itraconazole and 61.1% of those treated with fluconazole had negative results. Both drugs also resulted in a marked improvement in, or elimination of all clinical symptoms; however the improvement appeared to occur more rapidly with itraconazole. The overall assessment at the end of the 6 week follow-up showed that 88.2% of patients treated with itraconazole and 72.2% of those treated with fluconazole were cured with negative mycological tests. Adverse events were reported by one patient treated with itraconazole and 5 subjects receiving fluconazole. The only changes in laboratory parameters were elevated SGOT and SGPT values in one patient in the fluconazole group, who dropped out from the study. Discussion The results suggest that itraconazole is at least as effective as fluconazole in the treatment of tinea pedis and tinea manus, the onset of improvement in clinical symptoms is more rapid an prolonged after cessation of therapy with itraconazole, and that itraconazole appears to be better tolerated.     

Itraconazole versus griseofulvine in the treatment of tinea corporis and tinea cruris

126 patients (82 males and 44 females) aged above 12 years, suffering from tinea corporis and/or tinea cruris, were treated with either itraconazole (100 mg once a day for 2 weeks and then plecebo for 2 weeks) (63 patients), or griseofulvin (250 mg twice a day for 4 weeks). 90.47% of the patients treated with itraconzole improved whereas griseofulvin imporved 76.19% of patients, clinically. Mycological response was 72% with itraconazole and 57% with griseofulvin.     

1%盐酸布替萘芬乳膏治疗体股癣、足癣疗效观察

目的：评价1％盐酸布替萘芬乳膏治疗体股癣、足癣的临床疗效和安全性。方法：采用多中心、随机、双盲、平行对照的方法．试验组外用1％盐酸布替萘芬乳膏,对照组外用1％联苯苄唑乳膏。结果：体股癣患者停药时试验组与对照组痊愈率分别为32．76％和38．98％。有效率分别为93．10％和94．92％;停药2周时,试验组与对照组痊愈率分别为62．07％和64．41％,有效率分别为93．10％和96．61％。足癣患者停药时．试验组与对照组痊愈率分别为29．31％和30．00％．有效率分别为89．66％和85．00％;停药2周时,试验组与对照组痊愈率分别为48．28％和43．33％．有效率分别为91．38％和86．67％。局部不良反应发生率,两试验组为5．13％;两对照组为4．17％。上述各项指标,两组比较差异无统计学意义。结论：1％盐酸布替萘芬乳膏治疗体股癣、足癣安全有效。     

Efficacy and safety of terbinafine 1% solution in the treatment of interdigital tinea pedis and tinea corporis or tinea cruris

Two randomized, double-blind, vehicle-controlled, multicenter studies assessed the efficacy and safety of a new terbinafine 1% solution for the treatment of interdigital tinea pedis and tinea corporis or tinea cruris (tinea corporis/cruris). Patients with interdigital tinea pedis applied terbinafine 1% solution or vehicle twice daily for 1 week with 7 weeks of follow-up (N = 153), and patients with tinea corporis/cruris applied terbinafine 1% solution or vehicle once daily for 1 week with 3 weeks of follow-up (N = 66). Efficacy was assessed mycologically and clinically at the end of treatment and throughout follow-up. In the tinea pedis study, 66% of patients were effectively treated with terbinafine compared with 4% of the group treated by vehicle (P < .001; Mantel-Haenszel test). In the tinea corporis/cruris study, treatment was effective in 65% of the terbinafine group compared with 8% of the vehicle group (P < .001). There were no significant differences in the frequency of cutaneous adverse events between the 2 groups in either study. We conclude that one week of therapy with terbinafine 1% solution is highly effective, superior to vehicle, and safe for use in superficial fungal infections.     

One-week therapy with oral terbinafine in cases of tinea cruris/corporis

The use of oral terbinafine in the treatment of superficial dermatophyte infections has been extensively studied, using different treatment regimens. To evaluate the efficacy of short-term therapy with oral terbinafine in cases of tinea cruris/corporis. 22 patients (21 male and one female) with mycologically proven tinea cruris/corporis, were included in the present study. Each patient received one tablet of terbinafine 250 mg daily for 1 week. Patients were followed-up for 6 weeks after completion of treatment. Clinical and mycological assessments were performed at the end of treatment, and at the end of the follow-up period. The mean sum of scores of signs and symptoms in all patients decreased significantly from 12-36 before treatment to 0 at the end of the follow-up period, and mycological investigations were negative in all patients at the end of the follow-up period. Our results show that 1-week therapy with oral terbinafine is highly effective in the treatment of tinea cruris/corporis.     

利拉萘酯乳膏治疗体股癣及足癣的多中心随机双盲对照观察

目的 探讨2%利拉萘酯乳膏治疗体股癣、足癣的临床疗效和安全性。方法 采用多中心随机双盲阳性药平行对照法，分别在3个中心进行，入选288例患者，2%利拉萘酯乳膏试验组144例，1% 联苯苄唑乳膏对照组144例；每组中体股癣患者各72例，足癣患者各72例。每日涂药1次，足癣疗程4周，每2周复诊1次；体股癣疗程2周，每周复诊1次；停药后2周均再复诊1次。结果 试验组体股癣患者中有１例脱落。停药时体股癣试验组的痊愈率和有效率分别为59.2%和94.4%，足癣试验组分别为41.7%和81.9%，与对照组比较，差异均无统计学意义（P ＞ 0.05）。在用药结束后2周时，体股癣试验组的痊愈率和有效率分别为67.6%和94.4%，足癣试验组分别为54.2%和81.9%，与对照组比较，差异无统计学意义（P ＞ 0.05）。在用药结束后2周，体股癣和足癣试验组符合方案分析集真菌学清除率分别为97.18%和90.28%，试验组和对照组差异均无统计学意义（P ＞ 0.05）。用药后发生的不良反应表现为用药部位红肿、疼痛，其中体股癣试验组不良反应发生率为2.78%。结论 2%利拉萘酯乳膏治疗体股癣、足癣有良好的疗效和安全性。     

复方联苯苄唑液治疗浅部真菌病双盲对照研究

目的 为了研究复方联苯苄唑液对浅部真菌病的疗效。方法 采用双盲对照的方法。试验组为复方联苯苄唑液,对照组为克霉唑癣药水。均每日涂患部1次,疗程体股癣为2周,手足癣为4周,停药后随访2周,主要观察红斑、丘疹、水疱、鳞屑、角化和瘙痒,评价治疗后每周的皮损情况。每例患者于疗前、疗中及疗后,停药后2周作真菌学检查。结果 观察434例患者,复方联苯苄唑液临床治愈率体股癣为82.25%,手足癣为68.75%,总有效率体股癣为95.85%,手足癣为92.5%;对照组治疗体股癣痊愈率为58.6%,手足癣为44.7%,有效率体股癣为83.0%,手足癣为87.2%。临床350株常见致病菌,复方联苯苄唑液的MIC为1.6~12.5mg/L,克霉唑药水的MIC为3.125~25mg/L。结论 复方联苯苄唑液是高效、广谱的抗真菌药物。本药能溶解、松解角质,渗透性好,可长期应用。     

Comparative efficacy of topical 1% butenafine and 1% clotrimazole in tinea cruris and tinea corporis: a randomized, double-blind trial

Localized tinea cruris and tinea corporis can be treated by topical imidazoles (clotrimazole) or newer topical agents like butenafine, a benzylamine derivative with fungicidal activity. The therapeutic efficacy of these two agents was compared in this study. Eighty patients, diagnosed clinically to have tinea cruris or localized tinea corporis and confirmed on KOH examination, were randomly assigned to one of the two treatment groups in a double-blind manner; butenafine once daily for 2 weeks or clotrimazole twice daily for 4 weeks. Follow-up was done at 1, 2, 4 and 8 weeks. Clinical assessment score and KOH examination were performed at each visit. Butenafine recipients exhibited higher clinical cure as compared with clotrimazole recipients at the end of 1 week (26.5% vs 2.9%) as well as higher mycological cure (61.7% vs 17.6%). However, this difference was not statistically significant at 4 and 8 weeks of treatment.     

Italian multicentre trial comparing itraconazole with griseofulvin in the treatment of dermatomycoses. Preliminary results

The results of previous international studies have suggested that itraconazole is significantly superior to griseofulvin in the treatment of tinea corporis/cruris. The aim of our study was to compare the efficacy and tolerability of the two agents in a larger number of patients with dermatomycoses. This study is ongoing in 46 Italian Centers of Dermatology. From this total of 46 Centers, the patients of 16 Centers have been included for the "ad interim" analysis. One hundred and thirty-four patients were randomized to treatment with either itraconazole 100 mg once daily for 15 days (73 patients) or griseofulvin 375–1000 mg daily for a mean of 17 days (61 patients). The patients were assessed clinically and mycologically before entering the trial, at the end of therapy and again 30 days after the end of treatment. Both groups showed a statistically significant improvement in desquamation, erythema and subjective complaints, with a trend in favour of itraconazole, despite the significantly shorter duration of treatment. Thirty days after the end of therapy, microscopic results were negative in 91.5% of the itraconazole group and 71.7% of the griseofulvin group. Cultures were negative in 80% and 65%, respectively. A significantly higher proportion of patients in the itraconazole group than in the griseofulvin group experienced both clinical and mycological recovery. One patient in the itraconazole group and three in the griseofulvin group reported adverse experiences. The preliminary results of this study show that itraconazole is well tolerated and more effective than griseofulvin. Furthermore, itraconazole demonstrated a more rapid action than griseofulvin.     

Short treatment schedules of itraconazole in dermatophytosis

Patients were recruited from 1 December 1994 until 31 August 1995. Those presenting with tinea cruris/corporis received 200 mg of itraconazole every day for 7 days, whereas patients presenting with tinea pedis/manus were treated with 200 mg twice a day for 7 days. Those eligible were men and women at least 18 years of age, with a clinically diagnosed dermatophytosis, confirmed by KOH examination and culture. Pregnant or nursing patients and those who did not use adequate birth control methods were excluded. Patients with a known history of chronic liver disease or other concomitant serious disease were also excluded. Patients who had received any oral antifungal or corticosteroid therapy within 30 days before enrollment or any topical antifungal or corticosteroid treatment within a week before enrollment were not eligible.
Clinical and mycologic (KOH and culture) evaluation was carried out at baseline, at completion of therapy (day 7) and at the end of follow-up (day 28 for tinea cruris/corporis and day 35 for tinea pedis/manus). The investigator evaluated the following clinical symptoms at each visit: desquamation, erythema, infiltration, pruritus, exudation, maceration, vesiculation, and pustules. Clinical results were rated as: healed, markedly improved, considerable residual lesions, not changed, or worse. The categories healed and markedly improved were considered as responders.
All mycology was performed centrally at the Department of Microbiology, University of Malaya.     

国产伊曲康唑(美扶(R))治疗174例浅部真菌病临床观察

应用美扶R(伊曲康唑胶囊)200mg,每日2次,连服7天治疗手足癣100例及美扶R200mg,每日1次,连服7天治疗体股癣74例,3周后观察疗效。结果显示美扶R治疗手足癣的痊愈率及总有效率分别为49.49%和90.91%;体股癣则分别为73.33%和93.33%。美扶R对体股癣及手足癣的真菌清除率均达到了96%。     

Comparative study between terbinafine 1% emulsion-gel versus ketoconazole 2% cream in tinea cruris and tinea corporis

An open, prospective, comparative, randomised and parallel-group study of 65 patients was conducted to evaluate the efficacy and safety of topical 1 % emulsion-gel of terbinafine versus 2% ketoconazole cream in the treatment of tinea corporis and tinea cruris. Treatment for terbinafine emulsion-gel was applied once daily for 1 week, whereas ketoconazole cream was applied once daily for 2 weeks; patients were followed for 2 weeks. Thirty-three patients in the terbinafine group and 32 in the ketoconazole group were evaluated for efficacy and safety. At the end of the study, rates of mycological cure were 94% for terbinafine emulsion-gel and 69% for ketoconazole cream (p = 0.027). A clinical and mycological overall evaluation was obtained for 72% of patients receiving terbinafine emulsion gel and 31% of patients receiving ketoconazole cream (p = 0.002). A total of four patients (1 in the terbinafine group and 3 in the ketoconazole group) had contact dermatitis-like side effects. We conclude that a 1-week course of terbinafine 1% emulsion-gel is significantly more effective than ketoconazole 2% cream in the treatment of tinea corporis and tinea cruris as regards clinical and mycological cure and treatment safety.     

Wood灯在皮肤浅表真菌感染诊断中应用价值评估

目的 评估Wood灯在皮肤常见浅表真菌感染诊断中的应用价值.方法 对129例根据临床病史及体征初步诊断为皮肤浅表真菌感染患者进行Wood灯和真菌实验室检查.结果 花斑糠疹、马拉色菌毛囊炎患者Wood灯检查的阳性率分别为84%、85.7%,同时阳性病例的真菌培养或镜检的阳性率达92.9%、87.5%,两者有高度的一致性.而临床诊断手足癣和体股癣者其荧光阳性率只有8.3%.真菌总检出率却高达85.4%(41/48),两者不具有一致性.结论 Wood灯在花斑糠疹、马拉色菌毛囊炎的检查上有较高的特异性和敏感性,临床诊断上有应用价值,而对手足癣和体股癣诊断则无意义.

Abstract：

Objective To estimate the performance of Wood's lamp examination in the diagnosis of superficial cutaneous fungal infections. Methods Totally, 129 patients, who were diagnosed with superficial cutaneous fungal infections according to clinical medical history and signs, were enrolled in this study. Wood's lamp examination of lesions was carried out. Cutaneous samples were obtained from the patients and subjected to microscopic examination and fungal culture. Results Wood's lamp examination was positive in 84% and 85.7% of patients with tinea versicolor and malassezia folliculitis, respectively; among these patients positive for Wood's lamp examination, 92.9% were positive for fungal culture, and 87.5% for microscopic examination. In patients clinically diagnosed with tinea manus and pedis, tinea corporis or tinea cruris, 8.3% were positive for Wood's lamp examination, while 85.4% were positive for fungal examination. There was a high consistency between Wood's lamp examination and fungal examination in patients with tinea versicolor and malassezia folliculitis, but not in those with tinea manus and pedis, tinea corporis or tinea cruris. Conclusions Wood's lamp examination shows a high specificity and sensitivity and is useful in the diagnosis of tinea versicolor and malassezia folliculitis, but seems unapplicable for the diagnosis of tinea manus and pedis, tinea corporis or tinea cruris.     

利拉萘酯乳膏治疗手足癣和体股癣40例疗效观察

目的：评价2％利拉萘酯乳膏手足癣与体股癣的临床疗效及安全性，并与l％联苯苄唑乳膏进行比较。方法：对74例浅部真菌病患者进行治疗，其中治疗组40例，外用2％利拉萘酯乳膏，每日1次；对照组34例，外用1％联苯苄唑乳膏，每日1次。手足癣疗程4周，体股癣疗程2周。分别于停药及停药后2周观察患者的临床表现及治疗效果。结果：2％利拉萘酯乳膏和1％联苯苄唑乳膏临床疗效相似，停药时临床总有效率分别为87．50％和85．29％；停药后2周临床总有效率分别为97．50％和91．17％，两组总有效率比较差异均无统计学意义（P均〉0．05），无不良反应。结论：2％利拉萘酯乳膏治疗手足癣和体股癣使用方便，依从性好，安全，有效，是值得推广的一种新型外用抗真菌药。     

Once-weekly oral doses of fluconazole 150 mg in the treatment of tinea corporis/cruris and cutaneous candidiasis

Ninety-five adult out-patients with tinea corporis and/or tinea cruris participated in a multicentre open non-comparative study investigating the safety and efficacy of 1-4 once-weekly doses of oral fluconazole 150 mg. Trichophyton rubrum was isolated most frequently (67 of 86 mycologically evaluable patients). A mean of 2.6 doses of fluconazole was administered; patients infected with Candida albicans or Epidermophyton floccosum required an average of 2 doses compared to 3-4 doses in patients infected with other organisms. Clinical cure was obtained in 85 of 92 (92%) patients at the last post-treatment evaluation, with the remaining seven patients being substantially improved. At long-term follow-up, 28-30 days after the last dose, 80 of 91 (88%) patients were assessed as clinically cured, three (3%) patients were improved and eight (9%) patients failed. Among the long-term clinical failures, there was one diagnosis of tinea corporis (3% failure rate) and seven diagnoses of tinea cruris (12% failure rate). Mycological evidence of infection occurred in only 1 of 86 patients assessed at the last post-treatment follow-up. Mycological relapse occurred in nine (11%) patients at long-term follow-up; one patient was infected with Trichophyton mentagrophytes and eight patients were infected with T. rubrum. Relapse occurred in 2 of 29 (7%) patients with tinea corporis and eight of 57 (14%) patients with tinea cruris (one patient who relapsed had both tinea corporis and cruris). There was no correlation between the number of doses received and the mycological response or relapse rates at long-term follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)