CTRI/2009/091/001048已完成3 期
A MULTI-CENTRIC, OPEN-LABELED, PHASE III CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF EBERCONAZOLE AND MOMETASONE CREAM IN SUBJECTS WITH INFLAMED CUTANEOUS MYCOSIS
Dr Reddys Laboratories Ltd Hyderabad India0 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Adult patients of both genders aged between 18 and 65 years,who have signed informed consent
- •Must have a clinical diagnosis of Cutaneous mycoses supported by mycological diagnosis.
- •Total score of at least 3 on the scale of objective evaluation of severity of signs and symptoms.
- •Both male and female patients should use contraceptive measures to avoid pregnancy during the treatment period.
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs.
- •No other concurrent uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •If the patient is female;
- •?She must be of non-childbearing potential, i.e., surgically sterilized, or
- •?Must be negative on pregnancy test before starting therapy and must agree to continue such precautions thereafter for another one month
- •If the subject has received the antifungal treatment for Cutaneous mycoses, then a washout period of 30 days for systemic antifungal drugs and 2 weeks for topical antifungal agents has to be observed.
排除标准
- •1.Patients <18 and >66 years of age
- •2.Pregnant and lactating women
- •3.The subjects with Onychomycosis, Mocassin type, keratotic feet.
- •4.Life-threatening or serious cardiac diseases like cardiac failure/insufficiency (NYHA grades III-IV), respiratory, gastrointestinal, hepatic, renal, endocrine, Compromised circulation or immunologic disorder
- •5.Uncontrolled Hypertension
- •6.Uncontrolled Diabetes Mellitus
- •7.Any confirmed or suspected immunosuppressive or immuno- deficient condition
- •8.Clinically relevant abnormal hematology or biochemistry values, in the opinion of the Investigator
- •?Creatinine level ≥ 2 times of upper limit of normal
- •?Bilirubin ≥ 1.5 times of ULN
- •?Serum transaminases (ALT, AST) ≥3 times of ULN
- •9.Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug, ;
- •10.Have used systemic antifungal drugs within 30 days of first dose; or topical antifungal within 2 weeks of first dose.
研究者
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