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更新于：2026-08-17
Amorolfine Hydrochloride
盐酸阿莫罗芬
更新于：2026-08-17
概要
基本信息
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (1991-12-18), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C21H36ClNO |
InChIKeyXZKWIPVTHGWDCF-KUZYQSSXSA-N |
CAS号78613-38-4 |
关联
17
项与 盐酸阿莫罗芬 相关的临床试验CTRI/2025/12/099059
To evaluate the comparative efficacy and effectiveness of amorolfine nail lacquer vs clotrimazole lotion in the treatment of onychomycosis-A comparative study - nil
CTRI/2025/06/089309
Efficacy of combining CO2 laser with Amrolofine 5% nail laqure intreatment of Onychomycosis- An open label randomised controlled trial - NIL
NCT06689852
MULTICENTRIC, RANDOMIZED, EVALUATOR BLINDED CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS
100 项与 盐酸阿莫罗芬 相关的临床结果
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100 项与 盐酸阿莫罗芬 相关的转化医学
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100 项与 盐酸阿莫罗芬 相关的专利（医药）
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392
项与 盐酸阿莫罗芬 相关的文献（医药）2025-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Amorolfine hydrochloride cream and 2% crisaborole ointment: a study on their therapeutic benefits for keratotic tinea pedis
Article
作者: Du, Na ; Lv, Xinyan ; Yang, Jingyi ; Wang, Yixi ; Min, Wei
Objective The clinical effectiveness of 2% crisaborole cream and amorolfine hydrochloride cream on keratinized tinea pedis is the goal of this investigation. Methods Using random numbers, 100 patients with keratotic tinea pedis were split into two groups: the observation group received 2% crisaborole ointment and amorolfine hydrochloride cream once a night for four weeks, while the control group received white vaseline and amorolfine hydrochloride cream once a night. The two groups were compared in terms of clinical efficacy, adverse reaction incidence, and improvement in the dermatological quality of life index (DLQI) score. Results Following four weeks of treatment, the observation group's overall effective rate was 98%, which was significantly higher than 82%, and the difference was statistically significant (p < 0.001). The pruritus scales were (6.12 ± 1.92) days, (12.01 ± 3.89) days, (3.92 ± 3.02) days, and (15.09 ± 3.98) days in the control group. The observation group was significantly lower than the control group at both the 2-week and 4-week treatment points (p < 0.001). The incidence of negative effects did not differ significantly between the two groups (p > 0.05). Conclusions For keratinized tinea foot, 2% crisaborole ointment can increase the effectiveness of amorolfine hydrochloride cream.
2025-11-01MYCOSES
The First Isolation of Multiple Antifungal‐Drug‐Resistant
Trichophyton Rubrum
in China and the Novel Resistance Mechanism
Article
作者: Song, Ge ; Li, Xiaofang ; Liu, Weida ; Liang, Guanzhao ; Kong, Xue ; Zheng, Hailin ; Xiaodong She ; Tsui, Clement K. M. ; Xie, Wenting
ABSTRACT:
Objectives:
This study reports the first isolation of a multidrug‐resistant
Trichophyton rubrum
strain in China, characterizing its drug resistance profile and mechanisms.
Methods:
The isolate was identified by internal transcribed spacer (ITS) sequencing and phylogenetic analysis. In vitro antifungal susceptibility testing (AFST) was performed according to the M38‐A3 CLSI guideline to determine minimum inhibitory concentrations (MICs) against eight antifungals (terbinafine, itraconazole, fluconazole, amorolfine, griseofulvin, voriconazole, luliconazole and amphotericin B). Whole genome sequencing (WGS), transcriptome sequencing and qRT‐PCR were performed to explore the resistance mechanism.
Results:
The multidrug‐resistant
T. rubrum
strain L‐6424 was isolated from a Chinese patient with generalised tinea corporis/cruris, tinea unguium and tinea manuum. It exhibited elevated MICs to terbinafine (2 mg/L), itraconazole (0.5 mg/L), and amorolfine (0.5 mg/L). The phylogenetic tree based on genome‐wide single nucleotide polymorphisms (SNPs) showed L‐6424 is not a novel genotype of
T. rubrum
, with high genetic similarity (99.94%) with the reference strain (CBS 139224). There were three amino acid substitutions in the squalene epoxidase (SQLE), including the previously reported F397L and H440Y, as well as a newly discovered V105M, and one amino acid substitution in the CYP51A (R239C) was identified. Also, significant differences at the transcriptome level between the drug‐resistant and sensitive strains were observed, and it was screened and found that
CYP51A, TruMDR5
and
TERG_08139
may be related to azole resistance.
Conclusions:
Drug‐resistant
T. rubrum
has emerged in China, indicating the possibly increasing severity of antifungal resistance. The complex mechanism of multidrug‐resistant dermophytes poses challenges to clinical treatment, needing more attention.
2025-09-01Dermatologie (Heidelberg, Germany)
Article
作者: Odon, Astrid ; Batel, Janina ; Schäfer, Tim ; Braun, Martin ; Kämmerer, Eva ; Schaller, Martin ; Ressler, Lena ; Hirschsteiner, Oliver ; Sinnberg, Tobias ; Bröse, Elisabeth ; Bender-Säbelkampf, Sophia ; Grigorjan, Philipp ; Meder, Christine ; Sitaru, Cassian ; Klonowski, Esther ; Maronna, Andreas ; Voigt, Floras ; Walker, Birgit ; Müller, Lena ; Hofmann, Silke C ; Geißdörfer, Walter ; Nikolakis, Georgios ; Wamsler, Carolin ; Rausch, Susanne ; Hawlitschek, Christina ; Baldauf, Claudia ; Verma, Shyam B ; Wetzig, Tino ; Panzer, Rüdiger ; Krüger, Constanze ; Hoffmann, Michael ; Köhler, Lars ; Koch, Daniela ; Ardabili, Michael ; Jansen, Martin ; Montag, Andreas ; Rabe, Marie ; Ganser, Antje ; Averbeck, Marko ; Uhrlaß, Silke ; Nenoff, Pietro ; Hradetzky, Uta ; Richter, Linda ; Fischer, Eleni ; Müller, Valentina Laura ; Hoffmann, Johanna Maria ; Marxsen, Isabell ; Lange, Friederike ; Richter, Susanne ; Huynh, Julia ; Sticherling, Michael ; Deutsch, Cornelia ; Mütze, Hanna
Trichophyton (T.) mentagrophytes ITS genotype VIII/T. indotineae (TMVIII/TINDO) is a new, anthropophilic dermatophyte from the T. mentagrophytes/T. interdigitale complex that has gained increasing importance worldwide in recent years. This pathogen is characterized by frequent terbinafine resistance and a clinical picture of pronounced, inflammatory, and therapy-resistant dermatophytoses that predominantly affect the groin, trunk, extremities, and face. Between 2018 and the end of 2024, all TMVIII/TINDO cases detected in patients from Germany by culture and/or molecular biology were systematically recorded at the Leipzig-Mölbis laboratory. Identification and genotyping were performed by sequencing the internal transcribed spacer (ITS) region of the rDNA. In vitro resistance testing for terbinafine and itraconazole was performed using a breakpoint test. Additionally, the squalene epoxidase (SQLE) gene was sequenced to analyze resistance-associated point mutations. A total of 242 isolates from 196 patients were identified; some patients were consecutively detected repeatedly. The majority of affected patients had a migration background, particularly from South Asia (especially India) and Arab countries. Only a few infections were diagnosed in patients of German descent. As part of the diagnostic workup an in vitro susceptibility testing was performed using a breakpoint test, which demonstrated terbinafine resistance in 61.8% of the TMVIII/TINDO strains. Point mutations in the SQLE gene that correlated with resistance were found in a total of 161 of 188 strains. The most frequently detected mutation was Phe397Leu, which was associated with terbinafine resistance and clinical treatment failure with terbinafine in all cases. In addition, double mutations were detected in 26 strains. In vitro itraconazole resistance was observed in 11 of 186 tested isolates, corresponding to 5.9%. Itraconazole is currently the drug of choice for the systemic treatment of TMVIII/TINDO dermatophytoses. The recommended dosage is 100 mg twice daily for a period of 4-8 weeks, or up to 12 weeks if needed. Concurrent topical treatment with azoles, amorolfine, or ciclopirox is always recommended. In the event of itraconazole treatment failure, there are currently no standardized treatment recommendations. The off-label use of voriconazole has been reported in isolated cases, and there is also experimental experience with other active ingredients. The spread of TMVIII/TINDO in Germany and worldwide is particularly worrying in view of the dermatophyte's resistance to terbinafine and itraconazole.
100 项与 盐酸阿莫罗芬 相关的药物交易
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研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 传染性皮肤病 | 中国 | 2000-04-10 | |
| 皮肤念珠菌病 | 日本 | 1993-10-01 | |
| 银屑病 | 日本 | 1993-10-01 | |
| 足癣 | 日本 | 1993-10-01 | |
| 白癜风 | 日本 | 1993-10-01 | |
| 真菌病 | 日本 | 1991-12-18 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 50 | (Loceryl NL+Cosmetic Varnish) | 壓鹽鑰鹽鏇淵膚窪鑰壓(夢鏇範壓齋積壓蓋醖獵) = 醖醖製遞選蓋築願襯築 製淵鹹簾選鏇襯醖築獵 (積淵膚齋簾膚範醖襯襯, 9.1) 更多 | - | 2018-10-09 | ||
(Loceryl NL 12 Weeks) | 壓鹽鑰鹽鏇淵膚窪鑰壓(夢鏇範壓齋積壓蓋醖獵) = 顧衊獵糧齋窪窪餘構獵 製淵鹹簾選鏇襯醖築獵 (積淵膚齋簾膚範醖襯襯, 6.2) 更多 | ||||||
临床4期 | 20 | (Loceryl NL) | 襯鏇築窪願窪襯獵蓋遞 = 範網餘蓋構衊鬱構繭鬱 廠齋網鹽襯夢構齋簾鑰 (積獵淵遞繭網淵鏇齋築, 糧衊鹹醖鏇壓憲範簾簾 ~ 蓋淵願選壓醖觸鬱憲憲) 更多 | - | 2018-10-03 | ||
(Ciclopirox NL) | 襯鏇築窪願窪襯獵蓋遞 = 齋衊壓製淵繭製簾顧膚 廠齋網鹽襯夢構齋簾鑰 (積獵淵遞繭網淵鏇齋築, 廠願願鹹願鬱鏇膚齋糧 ~ 鹹選膚鏇積餘製蓋鏇繭) 更多 |
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