CTRI/2019/04/018560已完成4 期
An open label, prospective, observational, non-comparative, single arm clinical trial to evaluate the efficacy and safety of combination therapy with oral Itraconazole and topical Amorolfine in management of dermatophytosis.
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年4月22日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint will be total no. of patients achieving complete cure. (Complete cure is defined as patients achieving both clinical and mycological cure at the end of therapy)
研究概览
简要总结
This is an open label, prospective, observational,non-comparative, single arm clinical trial to evaluate the efficacy of combination of itraconazole andamorolfine in patients with multi-site or multi-lesional dermatophytosis. The study will be conducted for 6 weeks on male andfemale patients aged ≥ 18 years and ≤ 60 years .
Itraconazolewill be given in a dose of 100 mg/day orally for period of 4 weeks, whileamorolfine 0.25% will be applied topically twice daily for a period of 6weeks. The patients would be called for regular follow up as per the schedule.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Both male and female patients aged ≥ 18 years and ≤ 60 years.
- •2.Patients with multi-site, multi-legional dermatophytic infection (tinea infection).
- •3.Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol, among others a negative urine pregnancy test in the case of women of childbearing age.
- •4.Patients who the study staff deems reliable and mentally competent to carry out the study.
排除标准
- •1.Pregnant or nursing females.
- •2.Patients with known hypersensitivity to the study drugs.
- •3.Patients with immunosuppressive disease or on immunosuppressive drugs.
- •4.Patients with liver dysfunction.
- •5.Patients with a history of seizures 6.Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject’s safety or interfere with the study assessments.
- •7.Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subject’s ability to safely complete the study.
- •8.History of drug or alcohol dependency or abuse within approximately the last 2 years.
- •9.Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
- •10.Any patient whom the investigator judged to be inappropriate for this study.
结局指标
主要结局
The primary efficacy endpoint will be total no. of patients achieving complete cure. (Complete cure is defined as patients achieving both clinical and mycological cure at the end of therapy)
时间窗: 6 weeks
次要结局
- 1. No. of patients achieving clinical cure. (Clinical cure is defined as clear or almost clear symptoms [scaling, pruritus, erythema and incrustation] at the end of therapy)(2. No. of patients achieving mycological cure. (Mycological cure is defined as negative microscopy under potassium hydroxide (KOH) examination at the end of therapy.))
研究者
研究点 (1)
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