Assessment of efficacy and safety of Lipid based Amphotericin B gel 0.1% (Amfy gel®) in patients with moderate to severe vulvovaginal candidiasis

Phase 4

Completed

• Conditions: Candidiasis of vulva and vagina,

• Registration Number: CTRI/2014/02/004409
• Lead Sponsor: Intas Pharmaceuticals Ltd

Brief Summary

Vulvovaginal candidiasis(VVC) is a common problem in women worldwide, with 75 per cent of women experiencingsymptomatic disease at least once throughout their childbearing years.Anti-fungal azoles, including clotrimazole, fluconazole and imidazoleadministered as topical cream, vaginal pessary or oral tablets remain thestandard of care and are effectivein about 70-90% of cases. About 20% ofpatients fail treatment, i.e remain symptomatic and culture positive followinga single standard dose or short course of treatment with anti-fungal azoles.The causes for treatment failure include poor compliance, non-albicansinfection or severe disease.

Amphotericin B is apolyene antifungal drug, often used for systemic fungal infections, produced byStreptomyces nodosus. Amphotericin B associates with ergosterol, the maincomponent of fungal cell membranes, forming a transmembrane channel that leadsto monovalent ion (K+, Na+, H+ and Cl-) leakage, which is the primary effectleading to fungal cell death. It is broad spectrum Antifungal drug and quiteeffective against yeasts (Candida albicans, Candida neoformans), endemicmycoses (Histoplasma capsulatum, Blastomyces dermatitidis and Coccidiodes immitis) and pathogenic molds(Aspergillus  fumigatus andMucormycosis).

The Amfy® gel (Lipid BasedAmphotericin B Gel 0.1%) has been approved by the regulatory authorities formarketing in India. As a part of the extended monitoring efforts to monitor thesafety and efficacy of the gel, this post marketing surveillance study is beingconducted in the patients of Vulvovaginal candidiasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-20
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 1.Female patients’ ≥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 – 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

• 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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with clinical cure	At the end of 14 day course of treatment.

Secondary Outcome Measures

Name	Time	Method
•Any adverse event reported voluntarily, observed or enquired during the safety period	•Proportion of patients with negative KOH wet mount test at the end of 14 day course of treatment.

Trial Locations

Locations (5)

Anand Multispeciality Hospital Pvt Ltd; 🇮🇳 Ahmadabad, GUJARAT, India

Medipoint Hospitals Pvt. Ltd; 🇮🇳 Pune, MAHARASHTRA, India

Muktai Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Nirmal Hospital Pvt Ltd,; 🇮🇳 Surat, GUJARAT, India

Sanjivani Superspeciality hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Anand Multispeciality Hospital Pvt Ltd

🇮🇳Ahmadabad, GUJARAT, India

Dr Purvi M Dave

Principal investigator

079-22868681

drmdave@gmail.com