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CTRI Number  CTRI/2014/02/004409 [Registered on: 17/02/2014] Trial Registered Prospectively
Last Modified On: 21/11/2018
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Assessment of efficacy and safety of Lipid based Amphotericin B gel 0.1% (Amfy gel®) in patients with moderate to severe vulvovaginal candidiasis  
Scientific Title of Study   A prospective, open label, multicenter clinical trial to assess efficacy and safety of Lipid based Amphotericin B gel 0.1% (Amfy gel®) in patients with moderate to severe vulvovaginal candidiasis after treatment failure with anti-fungal azoles. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
671-13_version01_dated06/12/2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Harshit Shah 
Designation  Assistant Project Manager  
Affiliation  Lambda Therapeutic Research Ltd 
Address  Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India 
Phone  07940202020  
Fax  07940202021  
Email  harshitshah@lambda-cro.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arpit K Prajapati 
Designation  Assistant Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India 
Phone  07940202020  
Fax  07940202021  
Email  arpitkprajapati@lambda-cro.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arpit K Prajapati 
Designation  Assistant Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota

GUJARAT
380061
India 
Phone  07940202020  
Fax  07940202021  
Email  arpitkprajapati@lambda-cro.com  
 
Source of Monetary or Material Support  
Intas pharmaceuticals Ltd. 
 
Primary Sponsor  
Name  Intas Pharmaceuticals Ltd 
Address  2nd Floor, Chinubhai Centre, Ashram Road, Ahmedabad 380-009, Gujarat, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Purvi M Dave  Anand Multispeciality Hospital Pvt Ltd  White House, Opp. Rajasthan Hospital, Shahibaug, 380004
Ahmadabad
GUJARAT 
079-22868681

drmdave@gmail.com 
Dr Dilip Walke  Medipoint Hospitals Pvt. Ltd  Medipoint Hospitals Pvt. Ltd, 241/1, New D.P. Road, Aundh, 411007
Pune
MAHARASHTRA 
020-27298081

dbwalke@hotmail.com 
Dr Shushil Shirish Chaudhari  Muktai Hospital  11 Shivaji Nagar, Opp. Fame Adlabs, Nashik Road,422006
Nashik
MAHARASHTRA 
0253-2422480

sdrsushil@gmail.com 
Dr Jagruti Desa  Nirmal Hospital Pvt Ltd,  Ring Road, Civil Street, Near Kadiwala School,395002
Surat
GUJARAT 
0261-2333999

drjagrutiydesai@gmail.com 
Dr Mamta Bhomia  Sanjivani Superspeciality hospital  1, Uday Park Soc, Near Sunrise park, Vastrapur,380015
Ahmadabad
GUJARAT 
079-26300411

mvb3.sanjivani@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Anand Institutional Ethics Committee, Ahmedabad (Dr. Purvi M. Dave)  Approved 
Muktai Hospital Ethics committee, Nashik (Dr. Sushil Shirish Chaudhari)  Approved 
Nirmal Hospital Pvt Ltd Ethics committee, Surat (Dr. Jagruti Desai)  Approved 
Pentamed Ethics Committee, Pune (Dr. Dilip Walke)  Approved 
Sanjivani Hospital Ethics Committee, Ahmedabad (Dr. Mamta Bhomia)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B373||Candidiasis of vulva and vagina,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amfy gel  Dose-0.1% Frequency-twice daily Mode of Administration-topical Duration of treatment-14 days  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  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.  
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients with clinical cure   At the end of 14 day course of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
• 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.
 
Throughout study drug administration period
(14 days)
At the end of 14 day course of treatment
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/02/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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

Amphotericin B is a polyene antifungal drug, often used for systemic fungal infections, produced by Streptomyces nodosus. Amphotericin B associates with ergosterol, the main component of fungal cell membranes, forming a transmembrane channel that leads to monovalent ion (K+, Na+, H+ and Cl-) leakage, which is the primary effect leading to fungal cell death. It is broad spectrum Antifungal drug and quite effective against yeasts (Candida albicans, Candida neoformans), endemic mycoses (Histoplasma capsulatum, Blastomyces  dermatitidis and Coccidiodes immitis) and pathogenic molds (Aspergillus  fumigatus and Mucormycosis).

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

 
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