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 Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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 subjectâ??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 subjectâ??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.

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