An open label, prospective, randomized, triple arm clinical study to compare the effectiveness of super bioavailable Itraconazolecapsules 130 mg OD vs conventional Itraconazole capsules 200 mg OD (2 capsules of CITZ 100 mg) vs conventional Itraconazole capsules 100 mg BD in the management of Glabrous tinea.

Dr Bela Shah0 个研究点目标入组 261 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1.Both male and female patients aged = 18 years and = 60 years.
•2.Patients with diagnosis of Glabrous tinea on KOH mount 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

•1. Pregnant or nursing females.
•2. Patients with known hypersensitivity to the study drugs.
•3. Patients with liver dysfunction.
•4. Patients with a history of seizures
•5. 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.
•6. 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.
•7. History of drug or alcohol dependency or abuse within approximately the last 2 years.
•8. 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.
•9. Patients with malignancy.
•10. Any patient whom the investigator judged to be inappropriate for this study

发起方

Dr Bela Shah