NCT00117767已完成3 期
Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Complete cure (negative mycology and clinical cure) rate at Week 10
研究概览
简要总结
Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum.
Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
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 (Investigator)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical diagnosis of tinea capitis confirmed by positive KOH determined by the central mycology laboratory.
- •Male or female patients who are at least 4 years old and no more than 12 years old.
排除标准
- •Patients having a medical condition that alters the absorption and/or metabolism of terbinafine (e.g. liver, renal disease etc.)
- •Patients receiving medication that may interfere with the evaluation of the drug's effect
- •Patients who have kerions requiring immediate treatment or treatment with systemic corticosteroids and/or systemic antibiotics
- •Patients with a history of liver disease or current/active liver disease or with elevation of livery enzymes outside of the normal range corresponding to their age
- •Patients who have received recent systemic or topical treatment for tinea capitis within the specified time periods (e.g. systemic antifungals within 2 months of screening visit, topical treatments [e.g. antifungals, corticosteroid preparations, zinc pyrithione or selenium sulfide or tar containing products] within 1 week of screening).
- •Patients with a history of systemic lupus erythematosus
研究组 & 干预措施
1
Experimental
Terbinafine
干预措施: Terbinafine hydrochloride (HCl) (Drug)
2
Active Comparator
Griseofulvin
干预措施: Griseofulvin (Drug)
结局指标
主要结局
Complete cure (negative mycology and clinical cure) rate at Week 10
次要结局
- Clinical cure rate at Week 10
- Mycological cure rate at Week 10
- Safety of terbinafine
研究者
研究点 (1)
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