Health Condition 1: B373- Candidiasis of vulva and vagina
Conditions
Interventions
Intervention1: Amfy gel: Dose-0.1%
Frequency-twice daily
Mode of Administration-topical
Duration of treatment-14 days
Control Intervention1: NA: NA
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with clinical cureTimepoint: At the end of 14 day course of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Any adverse event reported voluntarily, observed or enquired during the safety period â?¢ Proportion of patients with negative KOH wet mount test at the end of 14 day course of treatment. Timepoint: Throughout study drug administration period (14 days) At the end of 14 day course of treatment | — |
Countries
India
Contacts
Public ContactDr Arpit K Prajapati
Lambda Therapeutic Research Ltd
Outcome results
None listed