A Randomized,Double-Blind,Multi-Center Clinical Trial with Butenafine Hydrochloride 1% Aerosol Versus Bifonazole 1% Aerosol for the Treatment of Tinea Pedis,Tinea Corporis or Tinea Cruris
- VernacularTitle:1%盐酸布替萘芬喷雾剂与1%联苯苄唑喷雾剂治疗体股癣足癣的多中心随机、双盲对照研究
- Author:
Min LI
;
Jun GU
;
Zhigang BI
;
Yongnian SHEN
;
Guixia LU
;
Ying WANG
;
Meihua ZHANG
;
Weida LIU
- Publication Type:Journal Article
- Keywords:
Tinea;
Butenafine;
Bifonazole
- From:
Chinese Journal of Dermatology
2003;0(08):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the efficacy and safety of butenafine hydrochloride 1% aerosol in the treatment of tinea pedis,tinea cruris or tinea corporis.Methods A randomized,double-blind,multi-center clinical trial was conducted.Efficacy was assessed in terms of mycological cure,total clinical sign and symptom scores,and clinical response,at baseline,mid-term,end of study,and 2 weeks after treatment.Results One hundred and seventeen patients with tinea cruris or tinea corporis were randomly allocated to individual groups treated with either butenafine 1% aerosol (n = 58,male 53,female 5,age 29.45 ? 11.80,course of disease 3.0 ? 5.0 months) or bifonazole 1% aerosol (n = 59,male 49,female 10,age 34.12 ? 12.98,course of disease 3.0 ? 11.0 months).One hundred and nineteen patients with tinea pedis were also allocated to two groups treated with either butenafine (n = 59,male 59,age 22.97 ? 3.97,course of disease 24.0 ? 36.0 months) or bifonazole (n = 60,male 60,age 23.77 ? 4.12,course of disease 36.0 ? 48.0 months).The cure rates and total response rates were 25.86% vs.40.68%,and 86.21% vs.91.53%,in the study group and the control group,respectively,at the end of study,and 58.62% vs.74.58%,and 96.55% vs.96.61% in 2 weeks following-up,for the patients with tinea cruris or tinea corporis.Also,the cure rates and total response rates were 23.73% vs.25.00%,81.36% vs.78.33%,in the study group and the control group,respectively,at the end of study,and 37.29% vs.41.57% and 81.36% vs.90.00% in 2 weeks following-up,for the patients with tinea pedis.Local adverse reactions were recorded in 13 of butenafine group,and 20 of bifonazole group.The differences of above data between two groups were not statistically significant.Conclusion Butenafine hydrochloride 1% aerosol is effective and well tolerated for the treatment of tinea pedis,tinea cruris or tinea corporis.
