An open label, prospective, double arm clinical trial to compare the efficacy and safety of super bioavailable itraconazole capsules and itraconazole capsules in the management of corporis/cruris/faciei.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Efficacy assessments evaluation of fungal score consisting of lesional scoring and clinical severity scoring. Lesional scoring includes symptoms such as scaling, erythema, pruritus and lesion margin continuity and elevation. Clinical severity score body surface area (BSA) covered by the lesions.
研究概览
简要总结
This study is designed as open label, prospective, randomized, comparative,double arm, single center study to evaluate the efficacy, safety and tolerability of super bioavailableitraconazole in comparison with conventional itraconazole in patients with tinea corporis/cruris/faciei. Total 70 patients will be enrolled in the study , 35 in each arm and will be instructed about the dosage of the drugs. The patient would be called for regular follow up as per the schedule predefinedin the protocol. At the end of study all the patients will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Both male and female patients aged ≥ 18 years and ≤ 60 years.
- •2.Patients with diagnosis of tinea corporis/cruris/faciei requiring systemic antifungal therapy.
- •3.Female of child bearing potential, who is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom with spermicide, IUD, oral, injected, transdermal or implanted hormonal contraceptives).
- •4.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.
- •5.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.Patients with malignancy.
- •11.Any patient whom the investigator judged to be inappropriate for this study.
结局指标
主要结局
Efficacy assessments evaluation of fungal score consisting of lesional scoring and clinical severity scoring. Lesional scoring includes symptoms such as scaling, erythema, pruritus and lesion margin continuity and elevation. Clinical severity score body surface area (BSA) covered by the lesions.
时间窗: 4 weeks
Mycological cure will be assessed by doing KOH microscopy of sample of each patient at the start and end of the therapy.
时间窗: 4 weeks
次要结局
- Safety will be assessed by monitoring the following parameters for all the patients(The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs leading to study withdrawal will be summarized by treatment groups.)