A prospective, open label, multicenter clinical trial to assess efficacy and safety of Lipid based Amphotericin B gel 0.1% (Amfy gelÂ®) in patients with moderate to severe vulvovaginal candidiasis after treatment failure with anti-fungal azoles. - NA

Intas Pharmaceuticals Ltd0 个研究点目标入组 60 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.Female patientsâ?? >=18 years of age, on an acceptable form of birth control throughout treatment period.
•2.The patient willing to give written, signed and dated informed consent to participate in the study before initiating any study related procedure.
•3.Clinical diagnosis of symptomatic vulvovaginal candidiasis (score at screening and baseline visit >=7 â?? moderately severe cases) confirmed at screening visit by positive KOH wet mount test.
•4.History of completing a single standard dose or short course of treatment with anti-fungal azoles within three months of the current symptomatic episode of VVC.
•5.Patient complies with all clinical trial instructions and procedures.

•1.Pregnant or breastfeeding or planning to become pregnant during the treatment period.
•2.Diagnosed with disseminated candidiasis or requires systemic antifungal therapy.
•3.Has received any topical/systemic antifungal therapy within 7 days prior to visit 2 (baseline).
•4.Women suffering from other active infectious cause(s) of vulvovaginitis (e.g., Bacterial vaginosis, Trichomonasvaginalis, Chlamydia trachomatis, Neisseria gonorrhea, symptomatic Herpes Simplex Virus-1 (HSV-1), symptomatic HSV-2, or symptomatic human papilloma virus).
•5.Women with current use of any immunosuppressive drugs, including systemic or topical vaginal corticosteroids.
•6.Known case of Hypersensitivity or intolerance (e.g., elevation of liver enzymes) to Amphotericin B.
•7.Diagnosed with any concomitant condition that, in the opinion of the investigator, could interfere with the evaluation of efficacy or safety, or would make it unlikely that the patient would complete the study.

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