Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis

September 14, 2016 updated by: Medinova AG

Comparative Study of the Efficacy of 10.0 mg Dequalinium Chloride (Fluomizin®) and 100 mg Clotrimazole (Canesten®) for the Treatment of Vulvovaginal Candidiasis

A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients suffering from vulvovaginal candidiasis, to assess safety of the two medications during the treatment, and to evaluate women's satisfaction with the two treatments.

Study Overview

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bangkok Noi district
      • Bangkok, Bangkok Noi district, Thailand, 10700
        • Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Clinical signs and symptoms of vulvovaginal candididiasis as Total Severity Score, Total Severity Score of at least 4 (0-15: vaginal itching (0-3), vaginal burning or soreness (0-3), abnormal vaginal discharge (0-3),vulvo/vaginal erythema or edema(0-3), vulvar excoriation or fissure formation (0-3).
  • Direct microscopy (Wet smear) positive for yeast forms (hyphae/pseudohyphae) or budding yeasts.
  • normal vaginal pH (higher than 4.5) at baseline.
  • Women aged 18 - 45 years old.
  • Women can comply with all clinical trial instructions, and can return to all follow-up visits.
  • Signed Written Informed Consent to participate in this study.

Exclusion Criteria:

  • Recurrent vulvovaginal candidiasis(4 episodes of VVC in the last 12 months).
  • Women with other cause of vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections
  • Women using oral or vaginal antifungals within 2 weeks prior to enrolment and during the study.
  • Women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment and during the study.
  • Women using any antibiotic or anti-infective within 2 weeks prior to enrolment.
  • Cervicitis, abnormal PAP smear in the last 6 month.
  • Severe systemic diseases (HIV infection, diabetes mellitus, cancer, tuberculosis, autoimmune diseases, severe psychiatric conditions, etc.).
  • Women with confirmed Neisseria gonorrhoea or Chlamydia trachomatis.
  • Women having menstruation bleeding at enrolment.
  • Known or suspected hypersensitivity to one of the study medications, inclusive their excipients.
  • Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study.
  • Patient is relative of, or staff directly reporting to, the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluomizin vaginal tablets
Fluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7
One vaginal tablet for 6 days and 1 placebo tablet on day 7
Other Names:
  • 10 mg dequalinium chloride vaginal tablets
  • Donaxyl vaginal tablets
  • Naxyl vaginal tablets
Active Comparator: Canesten vaginal tablets
Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days
one vaginal tablet for 7 days
Other Names:
  • 100mg clotrimazole vaginal tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical cure rate
Time Frame: Control 1 at day 4 after therapy end
Clinical cure rate is defined as Total Severity Score (TSC) ≤ 2
Control 1 at day 4 after therapy end

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological cure rate
Time Frame: Control 1 at 4 days after therapy end
Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture
Control 1 at 4 days after therapy end
Therapeutic cure rate
Time Frame: Control 1 at 4 days after therapy end
Clinically and microbiologically cured
Control 1 at 4 days after therapy end
Individual clinical signs and symptoms
Time Frame: Control 1 at 4 days after therapy end
4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation
Control 1 at 4 days after therapy end
Presence of dyspareunia
Time Frame: Control 1 at 4 days after therapy end
yes/no
Control 1 at 4 days after therapy end
Direct microscopy (wet smear)
Time Frame: Control 1 at 4 days after therapy end
Presence or absence of Candida hyphea or spores
Control 1 at 4 days after therapy end
vaginal pH
Time Frame: Control 1 at 4 days after therapy end
Control 1 at 4 days after therapy end
Candida culture
Time Frame: Control 1 at 4 days after therapy end
positive / negative for Candida spp
Control 1 at 4 days after therapy end
Global assessment of efficacy
Time Frame: Control 1 at 4 days after therapy end
4-point rating scale assessed by investigator and patient
Control 1 at 4 days after therapy end
Patient Satisfaction
Time Frame: Control 1 at 4 days after therapy end
presence of vaginal discomfort, increased discharge, burning sensation
Control 1 at 4 days after therapy end
Adverse event
Time Frame: Control 1 at 4 days after therapy end
Number of participants experiencing an adverse event
Control 1 at 4 days after therapy end
Global assessment of tolerability
Time Frame: Control 1 at 4 days after therapy end
4-point rating scale by investigator and patient
Control 1 at 4 days after therapy end
Clinical cure rate
Time Frame: Control 2 at 6 weeks after therapy end
Clinical cure rate defined as Total Symptom Score TSC ≤ 2
Control 2 at 6 weeks after therapy end
Presence of external dysuria
Time Frame: Control 1 at 4 days after therapy end
yes/no
Control 1 at 4 days after therapy end
Microbiological cure rate
Time Frame: Control 2 at 6 weeks after therapy end
Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture
Control 2 at 6 weeks after therapy end
Therapeutic cure rate
Time Frame: Control 2 at 6 weeks after therapy end
Clinically and microbiologically cured
Control 2 at 6 weeks after therapy end
Individual clinical signs and symptoms
Time Frame: Control 2 at 6 weeks after therapy end
4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation
Control 2 at 6 weeks after therapy end
Presence of dyspareunia
Time Frame: Control 2 at 6 weeks after therapy end
yes/no
Control 2 at 6 weeks after therapy end
Direct microscopy (wet smear)
Time Frame: Control 2 at 6 weeks after therapy end
Presence or absence of Candida hyphea or spores
Control 2 at 6 weeks after therapy end
vaginal pH
Time Frame: Control 2 at 6 weeks after therapy end
Control 2 at 6 weeks after therapy end
Candida culture
Time Frame: Control 2 at 6 weeks after therapy end
positive / negative for Candida spp
Control 2 at 6 weeks after therapy end
Global assessment of efficacy
Time Frame: Control 2 at 6 weeks after therapy end
4-point rating scale assessed by investigator and patient
Control 2 at 6 weeks after therapy end
Patient Satisfaction
Time Frame: Control 2 at 6 weeks after therapy end
presence of vaginal discomfort, increased discharge, burning sensation
Control 2 at 6 weeks after therapy end
Adverse event
Time Frame: Control 2 at 6 weeks after therapy end
Number of participants experiencing an adverse event
Control 2 at 6 weeks after therapy end
Global assessment of tolerability
Time Frame: Control 2 at 6 weeks after therapy end
4-point rating scale by investigator and patient
Control 2 at 6 weeks after therapy end
Presence of external dysuria
Time Frame: Control 2 at 6 weeks after therapy end
yes/no
Control 2 at 6 weeks after therapy end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Manopchai Thamkhantho, Prof MD, Siriraj Gynaecologic ID and Female STD Unit, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

July 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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