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临床试验/NCT05862714
NCT05862714已完成1 期

Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor

Combined Military Hospital Abbottabad1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
164
试验地点
1
主要终点
Clinical Improvement Resolution of symptoms

研究概览

简要总结

Pityriasis versicolor (PV) also called tinea versicolor is a common superficial chronic fungal infection of the skin caused by species of lipophilic yeast known as Malassezia species. Itraconazole is an oral synthetic triazole while fluconazole is an oral synthetic bis-triazole compound. Only a few studies are available to find a direct comparison of the efficacy of single dose of oral fluconazole (400 mg) and oral itraconazole (1000 mg) in the treatment of PV. The objective of the study was to compare the efficacy of single dose fluconazole (400 mg stat) to single dose itraconazole (1000 mg stat) in the treatment of pityriasis versicolor in the local population of Pakistan.

详细描述

Pityriasis versicolor (PV) also called tinea versicolor is a common superficial chronic fungal infection of the skin caused by species of lipophilic yeast known as Malassezia species. Itraconazole is an oral synthetic triazole while fluconazole is an oral synthetic bis-triazole compound. These both acts by inhibiting the cytochrome-P450 dependent 14-alpha-demethylation step in the formation of ergosterol thereby impairing the functions of certain membrane bound enzyme systems, and ultimately inhibiting the growth of fungi. Both the drugs have been studied in different dose regimen, however, there are variable results in studies on this subject. There is still no standard drug and its dosage that can ensure complete cure. Fluconazole (300mg) in 2 doses with an interval of one week has been used effectively, however, fluconazole (400 mg) as a single dose has also been used, and found to cure the PV. Itraconazole 200 mg/day can be given in a dose of for 7 days however, higher concentrations of itraconazole in the stratum corneum are achieved that persist for 3-4 weeks so the drug is presumed to be effective even in a single dose. Therefore, only a few studies are available to find a direct comparison of the efficacy of single dose of oral fluconazole (400 mg) and oral itraconazole (1000 mg) in the treatment of PV. The objective of the study was to compare the efficacy of single dose fluconazole (400 mg stat) to single dose itraconazole (1000 mg stat) in the treatment of pityriasis versicolor in the local population of Pakistan.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All the patients above 18 years of age
  • Diagnosed with pityriasis versicolor

排除标准

  • Those patients who had received any antifungal treatment during last 1 month
  • pregnancy
  • lactation
  • history of renal disease hepatic disease or malignancy
  • history of hepatic disease
  • history of malignancy

研究组 & 干预措施

Group A Fluconazole

Active Comparator

Oral fluconazole (400 mg stat) given to patients.

干预措施: Fluconazole (Drug)

Group A Fluconazole

Active Comparator

Oral fluconazole (400 mg stat) given to patients.

干预措施: Itraconazole (Drug)

Group B Itraconazole

Active Comparator

Oral Itraconazole (1000 mg stat) given to patients.

干预措施: Fluconazole (Drug)

Group B Itraconazole

Active Comparator

Oral Itraconazole (1000 mg stat) given to patients.

干预措施: Itraconazole (Drug)

结局指标

主要结局

Clinical Improvement Resolution of symptoms

时间窗: 4 weeks

Efficacy of treatment was assessed by mycological test by making KOH mount at start of treatment and than at follow up at 4 weeks

Efficacy of treatment through KOH mount

时间窗: 4 weeks

Efficacy of treatment was assessed by mycological test by making KOH mount at start of treatment and than at follow up at 4 weeks

次要结局

未报告次要终点

研究者

发起方
Combined Military Hospital Abbottabad
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Aleena Nasir

Principal Investigator

Combined Military Hospital Abbottabad

研究点 (1)

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