Health Condition 1: B373- Candidiasis of vulva and vagina
Conditions
Interventions
Intervention1: Amfy® gel (Lipid Based Amphotericin B Gel 0.1%): The affected area should be cleaned and dried prior to the application. The gel should be applied gently on the affected area twice dai
Sponsors
Intas Pharmaceutical Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) The patient willing to give written, signed and dated informed consent to participate in the study before initiating any study related procedure. 2) Clinical diagnosis of symptomatic vulvovaginal candidiasis (score at screening and baseline visit >=7 â?? moderately severe cases according to Annexure I) confirmed at screening visit by positive KOH wet mount test. 3) Patient complies with all clinical trial instructions and procedures. 4) Patient agreed to abstain from sexual intercourse during the treatment period 5) Sexually active women, unless surgically sterile or postmenopausal, must use an effective method of avoiding pregnancy for at least 4 weeks prior to study treatment, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. It is the investigatorâ??s responsibility to ensure that the above points regarding an effective method of avoiding pregnancy are discussed with patient in detail and the patient agreed for this and it is documented in the source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy. Investigators will be encouraged to enrol patients with HIV infection, recurrent fungal infection or patient not responsive to conventional antifungal therapy as per investigatorâ??s discretion.
Exclusion criteria
Exclusion criteria: 1) Known case of Hypersensitivity or intolerance (e.g., elevation of liver enzymes) to Amphotericin B. 2) Pregnant or breastfeeding or planning to become pregnant during the study period. 3) Diagnosed with disseminated Candidiasis or requires systemic antifungal therapy. 4) Has received any topical/systemic antifungal therapy within 7 days prior to visit 2 (baseline). 5) 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. 6) Women suffering from vaginal Trichomonas infection or Gardnerella vaginalis infection or Chlamydial vaginal infection or other venereal diseases. 7) Actual menstruation at screening or expected menstruation within 7 days after visit 2 (baseline). 8) Known case of â??Cervical cancerâ?? or â??Intraepithelial lesion in situ of cervixâ??. 9) Use of Vaginal pessaries and rings used for contraception or hormonal replacement therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with therapeutic cure, defined as both mycological cure and clinical cureTimepoint: At the end of study (EOS) visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Average change in composite score of clinical cureTimepoint: At the end of treatment visit from baseline;Change in Patientâ??s assessment scoreTimepoint: Since baseline;Patient reported adverse events (serious and non serious events)Timepoint: Throughout the study;Proportion of patients with clinical cureTimepoint: At the end of study visit;Proportion of patients with therapeutic cure, defined as both mycological cure and clinical cureTimepoint: At the end of treatment (EOT) visit | — |
Countries
India
Contacts
Public ContactDr Ankit Ranpura
Lambda Therapeutic Research Ltd.
Outcome results
None listed