NCT00645242已完成3 期
An Open Label, Multicenter Trial Of Diflucan (Fluconazole) For 6 Weeks Given Once Daily To Pediatric Patients With Tinea Capitis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Combined clinical and mycological outcome at Week 6
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of fluconazole for the treatment of tinea capitis in pediatric patients aged 3 to 12 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients (aged 3-12 years)
- •Clinical diagnosis of tinea capitis
- •Direct microscopy (KOH) positive for fungal elements within or outside hair shaft
排除标准
- •Negative baseline KOH
- •Liver disease
研究组 & 干预措施
Arm A
Experimental
干预措施: fluconazole (Drug)
结局指标
主要结局
Combined clinical and mycological outcome at Week 6
时间窗: Week 6
次要结局
- Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10(Weeks 3, 6, and 10)
- Combined clinical and mycological outcome at Weeks 3 and 10(Weeks 3 and 10)
- Mycological outcome based on culture results at Weeks 3, 6, and 10(Weeks 3, 6, and 10)
- Culture results at Weeks 3, 6, and 10(Weeks 3, 6, and 10)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune SystemsCandidiasis, EsophagealHIV InfectionsNCT00002339Pfizer100
招募中
3 期
Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's DiseaseInflammatory Bowel DiseasesCrohn's DiseaseNCT06274554Weill Medical College of Cornell University120
已完成
3 期
Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)InfectionLymphomaLeukemiaNCT00075803Medical College of Wisconsin600
已完成
1 期
Drug-drug Interaction Study Between Fluconazole and Famitinib in Healthy SubjectsTumorNCT05147727Jiangsu HengRui Medicine Co., Ltd.22
已完成
1 期
A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult ParticipantsHealthyNCT03135106Janssen Research & Development, LLC54