Evaluation of efficacy and safety of flutrimazole cream 1% in the treatment of tinea pedis

Chinese Journal of Mycology　2016, Vol. 11 　Issue (1): 28-32.

Evaluation of efficacy and safety of flutrimazole cream 1% in the treatment of tinea pedis

WANG Ai-ping¹, WAN Zhe¹, GU Jun², XUN Jin-hua³, LI Min⁴, XI Li-yan⁵, HAO Fei⁶, ZHANG Jian-zhong⁷, ZHAO Guang⁸, YAO Cheng⁹, WANG Rui¹⁰, LIU Bo¹⁰, WANG Yu-mei¹⁰, LI Ruo-yu¹

1. Department of Dermatology & venereology, Peking University First Hospital, Beijing Key Laboratory of Molecular Diagnosis of Dermatoses, Beijing 100034;
2. Department of Dermatology, Changhai Hospital of Shanghai, Shanghai 200433;
3. Department of Dermatology, Huashan Hospital, Fudan University, Shanghai 200040;
4. Department of Dermatology & venereology, Zhongshan Hospital, Fudan University, Shanghai 200032;
5. Department of Dermatology, the Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou 510120;
6. Department of Dermatology and Venereology, Southwest Hospital, Third Military Medical University, Chongqing 400038;
7. Department of Dermatology, Peking University People's Hospital, Beijing 100044;
8. Department of Dermatology, Air Force General Hospital of PLA, Beijing 100036;
9. Medical Statistics Room, Peking University First Hospital, Beijing 100034;
1
0. Jiangsu Nhwa Pharmaceutical Co., LTD, Xuzhou 221009

Received:2015-06-30 Online:2016-02-28 Published:2016-02-28

Abstract

Abstract:

Objective To evaluation of efficacy and safety of flutrimazole cream 1% in the treatment of tinea pedis.Methods A multicentre,double-blind,randomised,non-inferiority study were conducted.Flutrimazole cream 1% or bifonazole cream 1% were applied once daily for 4 weeks to tinea pedis.Results The primary index of drug efficacy were determined by the total effective rates at week 4,71.43% in the flutrimazole group and 64.81% in bifonazole group(P=0.190).At week 6(week 2 after end of treatment),the total effective rates were 82.61% versus 71.60%(P=0.018),respectively;mycological cure rates were 86.16% versus 77.50%(P=0.045),respectively;the clinical effective rates were 93.50% versus 91.75%(P=0.504),respectively.Treatment-related adverse events consisted of local skin irritation,occurred in 2.44% versus 2.46%(P=1.000),respectively.Conclusion This study suggest that flutrimazole cream 1% was effective and safety in the treatment of tinea pedis.Flutrimazole cream 1% was found to be equally effective and non-inferior to bifonazole cream 1%.But the total effective rates of flutrimazole cream 1% at week 6 were superior to bifonazole cream 1%,mainly being reflected in the aspect of mycology curative effect.

Key words: flutrimazole, bifonazole, tinea pedis, efficacy, safety

CLC Number:

R756.3

WANG Ai-ping, WAN Zhe, GU Jun, XUN Jin-hua, LI Min, XI Li-yan, HAO Fei, ZHANG Jian-zhong, ZHAO Guang, YAO Cheng, WANG Rui, LIU Bo, WANG Yu-mei, LI Ruo-yu. Evaluation of efficacy and safety of flutrimazole cream 1% in the treatment of tinea pedis[J]. Chinese Journal of Mycology, 2016, 11(1): 28-32.

References

[1] 汪科,王爱平,李春阳,等.1%盐酸布替萘芬软膏治疗体股癣和足癣随机双盲临床试验[J].中国临床药理学杂志,2004,20(4):254-257.
[2] 王爱平,刘雯,金岚,等.2%利拉萘酯乳膏治疗足癣和体股癣疗效和安全性评价[J].中国真菌学杂志,2007,2(2):107-110.
[3] 马维莉.2%利拉萘酯软膏与1%联苯苄唑软膏治疗足癣的对照研究[J].医学临床研究,2007,1(1):42-44.
[4] 奚丹,王玉茹,纪黎明,等.1%联苯苄唑乳膏治疗手足癣及体股癣的临床研究[J].中国皮肤性病学杂志,2008,22(6):349-350.
[5] García Rafanell J,Dronda MA,Merlos M,et al.In vitro and in vivo studies with flutrimazole,a new imidazole derivative with antifungal activity[J].Arzneimittelforschung,1992,42(6):836-840.
[6] Merlos M,Vericat ML,García-Rafanell J,et al.Topical anti-inflammatory properties of flutrimazole,a new imidazole antifungal agent[J].Inflamm Res,1996,45(1):20-25.
[7] Ramis J,Conte L,Segado X,et al.Influence of formulation on the in vitro transdermal penetration of flutrimazole[J].Arzneimittelforschung,1997,47(10):1139-1144.
[8] Izquierdo I,Bayes M,Jané J,et al.Local and systemic tolerance of flutrimazole skin creams following single and repeated topical application in healthy volunteers[J].Arzneimittelforschung,1992,42(6):859-860.
[9] Duchène P,Papalexiou P,Ramis J,et al.Pharmacokinetic profile of flutrimazole following single topical application in normal and scarified skin of healthy volunteers[J].Arzneimittelforschung,1992,42(6):861-863.
[10] Velasco A,Román C,Aragüés M,et al.Comparison of the efficacy of 1% flutrimazole cream twice a day with 1% flutrimazole cream once a day for the treatment of superficial dermatophytoses[J].Rev Iberoam Micol.,2002,19(3):169-172.
[11] Alomar A,Videla S,Delgadillo J,et al.Flutrimazole 1% dermal cream in the treatment of dermatomycoses:a multicentre,double-blind,randomized,comparative clinical trial with bifonazole 1% cream.Efficacy of flutrimazole 1% dermal cream in dermatomycoses[J].Dermatology,1995,190(4):295-300.

[1]	CHEN Wei, ZHANG Xiao-mei, WAN Zhe, LI Ruo-yu, YU Jin, WANG Ai-ping, LIU Wei. Biosafety proposal for fungal examination in combating COVID-19 infection [J]. Chinese Journal of Mycology, 2020, 15(1): 6-9.
[2]	ZHANG Huan-mei. Observation of the efficacy of luliconazole cream combined willow acid solution sprays in malassezia folliculitis [J]. Chinese Journal of Mycology, 2020, 15(1): 52-54.
[3]	HE Yuan-hong, TAN qing, YANG Tong-tong, HE Sheng-hua, WANG Yin, ZHOU Rui-feng, CAI Lin. Efficacy and safety of amphotericin B in 124 AIDS-associated cryptococcal meningitis patients [J]. Chinese Journal of Mycology, 2019, 14(6): 346-350.
[4]	FU Jie, WU Bin. Meta-analysis of the efficacy and safety of naftifine hydrochloride and ketoconazole cream for the dermatomycoses [J]. Chinese Journal of Mycology, 2019, 14(5): 270-276.
[5]	ZHU Hong-mei, LIANG Xiao-bo, WEN Hai, LI Bin. Traditional herb lotion combined with topical antifungal therapy in the treatment of Malassezia folliculitis [J]. Chinese Journal of Mycology, 2019, 14(5): 277-279.
[6]	ZHAO Yi-ding, TIAN Gai-miao, SUN Dan, YAN Xiao-ning. Clinical observation and drug sensitivity test of TaXi power in the treatment of tinea pedis [J]. Chinese Journal of Mycology, 2019, 14(4): 240-244.
[7]	CHEN Rong, LIU Min, ZHANG Wei. Diagnosis value of combined detection of serum PCT and plasma 1,3-β-D-glucan in the autoimmune diseases with invasive pulmonary fungal infection [J]. Chinese Journal of Mycology, 2018, 13(6): 335-339.
[8]	SHANG Pan-pan, WANG Ai-ping. Safety analysis of itraconazole clinical application [J]. Chinese Journal of Mycology, 2018, 13(6): 376-379.
[9]	HUANG Meng-ya, ZHAO Ming-dan, WANG Jin-shu, ZHAO Mi-mi, ZHOU Xun. Clinical epidemiological investigation and pathogenic analysis of 135 tinea pedis cases in Chongqing [J]. Chinese Journal of Mycology, 2018, 13(5): 290-293.
[10]	WANG Mei-fang, LI Lin-feng, CHENG hai-yan, CHEN Ze-yu, TIAN Ke. Efficacy of 1% sulconazole nitrate spray in the treatment of tinea pedis and preventive effect of spraying the shoes and socks [J]. Chinese Journal of Mycology, 2018, 13(3): 164-167.
[11]	WANG Qun, ZHANG Qiang, HUANG Jing, HAN Shu-hua, ZHU Xiao-li. High risk factors and clinical efficacy of pulmonary fungal infection in patients with acute exacerbation of chronic obstructive pulmonary disease [J]. Chinese Journal of Mycology, 2018, 13(1): 15-19.
[12]	WEI Jin-ying, OUYANG Yan-yin, CAI Shuang-qi, LIANG Hao, CAO Cun-wei. Administration of voriconazole in disseminated penicilliosis marneffei: a retrospective study [J]. Chinese Journal of Mycology, 2017, 12(2): 92-97.
[13]	LEI Wen-zhi, DU Lin, WEI Feng-lian, LIAO Wan-qing, WEN Hai. A randomized,double-blind,controlled study with luliconazle cream (1%) versus terbinafine cream (1%) in patients with tinea cruris [J]. Chinese Journal of Mycology, 2017, 12(1): 38-41.
[14]	YANG Jing, DONG Bi-lin, JIANG Ping, YIN Jing, CHEN Zun-yi, ZHANG Wei-ming, XIA Fan, LAI Bin, TONG Zhong-sheng. Evaluation of clinical efficacy of 1% luliconazole cream in the treatment of tinea pedis [J]. Chinese Journal of Mycology, 2017, 12(1): 45-48.
[15]	ZHAO Huai-Bo, FAN Bin. Tinea pedis and erysipelas on lower legs [J]. Chinese Journal of Mycology, 2017, 12(1): 49-51.