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.     

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。     

特比萘芬软膏与疗霉舒软膏随机对照治疗浅部真菌病多中心临床研究

目的　比较研究山东齐鲁制药厂生产的１ ％ 特比萘芬软膏和诺华公司生产的１ ％ 疗霉舒软膏治疗浅部真菌病的有效性和安全性。方法　随机、多中心临床研究。两种药物的用药剂量和疗程相同，外涂患处，每日２ 次，体股癣、花斑癣疗程１ 周，手足癣和皮肤念珠菌病疗程２ 周。结果　１ ％ 特比萘芬软膏治疗浅部真菌病，临床治愈率为７０ ．８ ％ ，总有效率９６ ．２ ％ ，真菌清除率为９０ ．６ ％ ，不良反应发生率０ ．９ ％ ；对照组疗霉舒临床治愈率为７４ ．５ ％ ，总有效率９７ ．１ ％ ，真菌清除率为９３ ．１ ％ ，不良反应发生率为２ ．０ ％ 。两种药物治疗浅部真菌病的临床疗效和安全性在统计学上差异均无显著性意义。结论１ ％ 特比萘芬软膏治疗浅部真菌病疗效好、安全性高，与１ ％ 疗霉舒软膏比较疗效相似。     

1%盐酸特比萘芬软膏治疗浅部真菌病临床观察

目的：评价1％盐酸特比萘芬软膏治疗浅部真菌病的疗效及安全性。方法：40例浅部真菌病病人外用1％盐酸特比萘芬软膏，每日2次，体股癣和花斑癣疗程2周，手足癣4周；停药及停药2周时评价疗效及安全性。结果：停药时总有效率为92．5％，真菌总清除率为95％；停药2周时总有效率为95％，真菌总清除率为97．5％；不良反应率2．5％。结论：1％盐酸特比萘芬软膏治疗浅部真菌疗效显著且安全。     

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。     

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.     

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.     

萘替芬酮康唑乳膏治疗体股癣疗效观察

目的评价萘替芬酮康唑乳膏(必亮乳膏)治疗体股癣的疗效。方法100例患者随机分为治疗组和对照组各50例,分别外用萘替芬酮康唑乳膏、硝酸咪康唑乳膏,均早晚各1次,疗程4周。在治疗的第2,4周和停药1周时观察记录患者皮损变化、不良反应及皮损处皮屑真菌镜检,并评价疗效。结果治疗的第4周和停药1周时,治疗组疗效明显优于对照组(P(0.05),治疗组和对照组局部不良反应发生率分别为6.00%,4.00%,症状较轻,均能坚持治疗。结论外用萘替芬酮康唑乳膏(必亮乳膏)治疗体股癣疗效较好,不良反应发生率低。     

Short-duration therapy with terbinafine 1% cream in dermatophyte skin infections

Summary In a multicentre, double-blind, parallel-group study, the efficacy and safety of a single application of terbinafine 1% cream was compared with 3, 5 and 7 days' once-daily therapy in the treatment of tinea pedis and tinea corporis/cruris.
Seventy-eight patients with tinea pedis (58 male, 20 female; mean age 36, range 19–80) and 21 patients with tinea corporis or tinea cruris (16 male, 5 female; mean age 37, range 22–72), presenting in general practice, were entered into the study. Of these, 65 patients with tinea pedis and 14 with tinea corporis or cruris completed the study and were evaluable.
Twenty-eight days after commencing therapy 78, 83, 82 and 83% of patients with tinea pedis in the 1-, 3-, 5-, and 7-day treatment groups, respectively, were mycologically cured, and 61, 78, 71 and 67%, respectively, were 'effectively treated'. There was no statistically significant difference between treatment groups. Similarly high cure rates were seen in patients with tinea corporis and tinea cruris. Three months after commencing therapy there was little evidence of relapse.
The study shows that there is a significant potential for short-duration therapy with terbinafine 1% cream in tinea infections of the skin, emphasized here by the high cure rates obtained following a single application.     

利拉萘酯软膏治疗体股癣的临床研究

目的探讨利拉萘酯软膏治疗体股癣的疗效和安全性。方法采用多中心、随机双盲、有效对照、平行分组法对144例体股癣患者进行了4周的临床研究。结果138例患者完成临床观察并纳入统计分析,其中试验组71例,对照组67例,试验组治愈率为46.48%,对照组为40.30%,两组有效率分别为83.10%和83.58%,真菌清除率分别为95.83%和95.65%;不良反应发生率分别为0.70%和0。两组之间的临床治愈率、有效率和真菌清除率及不良反应率差异均无显著性。结论2%利拉萘酯软膏治疗体股癣综合疗效和不良反应发生率与1%联苯苄唑软膏相似,具有较好的疗效和安全性。     

复方联苯苄唑乳膏治疗体股癣随机双盲对照临床试验

目的　评价复方联苯苄唑乳膏治疗体股癣的临床疗效及安全性。方法　采用随机双盲、有效对照、平行分组试验 ,与 1%联苯苄唑霜作对照比较。结果　观察了可供疗效评价的体股癣病例 67例 ,其中试验组 3 4例 ,对照组 3 3例。试验组治愈率 79.41% ,对照组为 72 .73 % ,两组有效率分别为 85 .2 9%和 81.82 % ,真菌清除率为 83 .87%和 80 .65 % ,不良反应发生率为 2 .86%和 0。两组的临床治愈率、有效率和真菌清除率及不良反应发生率差异均无显著性。但在治疗中 (第 1周 )试验组和对照组的有效率分别为 5 0 .0 0 %和 3 3 .3 3 % ,差异有非常显著性 (P <0 .0 0 5 )。结论　复方联苯苄唑乳膏治疗体股癣综合疗效和不良反应发生率与 1%联苯苄唑霜相似 ,但复方联苯苄唑乳膏治疗体股癣比 1%联苯苄唑霜起效快 ,具有很好的疗效和安全性。     

O.25%盐酸阿莫洛芬霜治疗体股癣多中心的临床试验

目的评价0.25%盐酸阿莫罗芬霜治疗体股癣临床非劣效性及安全性.方法101例患者入选,采用随机单盲、阳性药(1%联苯苄唑霜)平行对照临床试验,根据临床症状改善及病原学检查、不良反应发生情况评价治愈率及安全性.结果试验组和对照组治愈率分别为80.0%、73.3%(P＞0.05,RR 1.09,C10.87-1.37);直接显微镜检查真菌阴转率分别为82.2%和73.3%(P＞0.05);真菌培养清除率分别为80.0%和73.3%(P＞0.05).个别患者发生与研究药物有关的不良反应,主要表现为红斑、瘙痒、灼热感、脱屑,不影响治疗,均自行缓解.ITT分析结果相似.结论0.25%盐酸阿莫罗芬霜治疗体股癣高效安全,且临床疗效、真菌学疗效和安全性均与1%联苯苄唑霜相似.     

Topical treatment of interdigital tinea pedis: terbinafine compared with clotrimazole

A multicentre, prospective, randomized, double-blind, parallel group study was undertaken to compare the efficacy and tolerability of topical terbinafine with topical clotrimazole in the treatment of interdigital tinea pedis. Patients were randomized to receive either terbinafine 1% cream twice daily for 1 week, followed by a similar placebo cream for 5 weeks, or clotrimazole 1% cream twice daily for 4 weeks. Outcome measures were: (i) mycological cure (negative culture); (ii) effective treatment (negative culture plus a symptom score of 2 or less out of a maximum score of 18); and (iii) complete cure (negative culture and a symptom score of 0); measured at 1, 4, 8 and 12 weeks after the commencement of the study. One hundred and four of the 217 patients randomized had a culture-confirmed dermatophyte infection at baseline. In these patients, 84.6% in the terbinafine group were culture negative after 1 week, compared with only 55.8% in the clotrimazole group. Both agents were well tolerated. The study showed that terbinafine achieves mycological cure more rapidly than clotrimazole. This may result in improved compliance and better control over transmission of infection.     

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。     

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。     

Efficacy and Safety of Terbinafine Hydrochloride 1% Cream vs. Sertaconazole Nitrate 2% Cream in Tinea Corporis and Tinea Cruris: A Comparative Therapeutic Trial

Context:

To the best of our knowledge, till date no study comparing the efficacy and safety of terbinafine hydrochloride 1% cream and sertaconazole nitrate 2% cream has been done in localized tinea corporis and tinea cruris.

Aims:

This clinical trial was carried out to study and compare the efficacy of topical terbinafine hydrochloride 1% cream and sertaconazole nitrate 2% cream in localized tinea corporis and tinea cruris and to know the adverse effects of these antifungal creams.

Settings and Design:

In this prospective, single blind, randomized control trial with two arms, patient were randomized into two groups Group A (treatment with terbinafine cream) and Group B (treatment with sertaconazole cream). A total of 38 patients were enrolled for the study, 20 patients in group A and 18 patients in group B. But five patients of group A and three patients of group B were lost for follow-ups. Therefore sample size was of 30 patients with 15 patients in group A and group B each.

Materials and Methods:

Patients in group A and B were treated with twice daily topical 1% terbinafine hydrochloride and 2% sertaconazole nitrate cream respectively for a total duration of three weeks. Clinical improvement in signs and symptoms of each clinical parameter, namely itching, erythema, papules, pustules, vesicles, and scaling were graded weekly and clinical cure was assessed. KOH mount and culture was done weekly up to 3 weeks to access mycological cure. Fungal culture was done on Sabouraud''s dextrose agar with chloramphenicol and cycloheximide.

Statistical Analysis Used:

Statistical analysis was done using students paired and unpaired t-tests from the data obtained.

Results:

Comparison between Group A and Group B for complete cure (clinical and mycological) showed that at the end of 3 weeks both terbinafine and sertaconazole groups had 100% complete cure. When the two groups were compared for complete cure, at the end of 1^st and 2^nd week, statistically non-significant results were observed (P = 0.461 and P = 0.679 respectively). However, at the end of 2^nd week, complete cure rate for terbinafine was 80% as compared to 73.35% for sertaconazole with no statistical significance. In both Group A and Group B, clinically significant local side effects like erythema, swelling, stinging sensation, or increased itching were not noticed. A majority of our patients in both the group showed Trichophyton rubrum followed by Trichophyton mentagrophytes growth on culture. In Group A, 11 patients showed growth of T. rubrum, 2 patients showed growth of T. mentagrophytes, and 1 patient had only KOH test positive. In Group B, 10 patients revealed growth of T. rubrum, followed by growth of T. mentagrophytes in 3 and Microsporum canis in 2 patients. The therapeutic response is more or less same in infection with different species.

Conclusions:

The newer fungistatic drug sertaconazole nitrate 2% cream was as effective as terbinafine hydrochloride 1% cream which is one of the fungicidal drugs, though terbinafine hydrochloride 1% cream has higher rates of complete cure at the end of 2 weeks as compared to sertaconazole nitrate 2% cream. Both the drugs showed good tolerability with no adverse effects.     

Comparison of one week of oral terbinafine (250 mg/day) with four weeks of treatment with clotrimazole 1% cream in interdigital tinea pedis

Treatment of interdigital tinea pedis often involves long-term therapy with topically applied preparations. Effective oral preparations, such as the allylamine terbinafine (Lamisil), taken over a shorter period, could provide a useful therapeutic alternative. A total of 269 patients from five centres with clinically diagnosed interdigital tinea pedis were entered into this double-blind, randomized, double-dummy, parallel-group study comparing oral terbinafine 250 mg once daily for 1 week with 1% clotrimazole (Canesten) cream applied twice daily for 4 weeks. Of these, 137 patients were evaluable for efficacy (confirmed dermatophyte infection by microscopy and culture): 63 terbinafine and 74 clotrimazole. At week 4, the mycological cure rates (negative culture at week 1 and negative results on microscopy and culture at week 4 onwards) were very similar (71% for clotrimazole and 72% for terbinafine). There was a faster response rate in the terbinafine group with respect to signs and symptoms at week 1. Both treatments were equally well tolerated; adverse events occurred equally in the two groups. In conclusion, oral terbinafine in a single daily dose of 250 mg for 1 week is as effective and as well tolerated as 1% clotrimazole cream applied twice daily for 4 weeks in the treatment of interdigital tinea pedis.     

1%盐酸布替萘芬乳膏治疗浅部真菌病临床观察

目的：评价1％盐酸布替萘芬乳膏治疗浅部真菌病的临床疗效及安全性，并与1％联苯苄唑凝胶进行比较。方法：对83例浅部真菌病患者进行治疗，其中治疗组43例，外用1％盐酸布替萘芬乳膏，每日1次；对照组40例，外用1％联苯苄唑凝胶，每日1次，体股癣疗程2周，手足癣4周。分别于停药及停药2周时观察记录患者的临床表现及治疗效果。结果：1％盐酸布替萘芬乳膏和1％联苯苄唑凝胶临床疗效相似，停药时临床总有效率分别为90．7％和90．0％，真菌总清除率为93．0％和90．0％；停药2周时临床总有效率分别为97．7％和92．5％，真菌总清除率为100．0％和92．5％。不良反应少。结论：1％盐酸布替萘芬乳膏治疗浅部真菌病疗效显著且安全。     

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.     

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.