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

Primary Purpose

Vulvovaginal Candidiasis

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Fluomizin vaginal tablets
Canesten vaginal tablets
Sponsored by
Medinova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiasis focused on measuring vulvovaginal candidiasis, vulvovaginal candidosis, mycotic vaginal infection, dequalinium chloride, Fluomizin, clotrimazole, canesten

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fluomizin vaginal tablets

Canesten vaginal tablets

Arm Description

Fluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7

Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days

Outcomes

Primary Outcome Measures

Clinical cure rate
Clinical cure rate is defined as Total Severity Score (TSC) ≤ 2

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2013
Last Updated
September 14, 2016
Sponsor
Medinova AG
Collaborators
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02242695
Brief Title
Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis
Official Title
Comparative Study of the Efficacy of 10.0 mg Dequalinium Chloride (Fluomizin®) and 100 mg Clotrimazole (Canesten®) for the Treatment of Vulvovaginal Candidiasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medinova AG
Collaborators
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis
Keywords
vulvovaginal candidiasis, vulvovaginal candidosis, mycotic vaginal infection, dequalinium chloride, Fluomizin, clotrimazole, canesten

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluomizin vaginal tablets
Arm Type
Experimental
Arm Description
Fluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7
Arm Title
Canesten vaginal tablets
Arm Type
Active Comparator
Arm Description
Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Fluomizin vaginal tablets
Other Intervention Name(s)
10 mg dequalinium chloride vaginal tablets, Donaxyl vaginal tablets, Naxyl vaginal tablets
Intervention Description
One vaginal tablet for 6 days and 1 placebo tablet on day 7
Intervention Type
Drug
Intervention Name(s)
Canesten vaginal tablets
Other Intervention Name(s)
100mg clotrimazole vaginal tablets
Intervention Description
one vaginal tablet for 7 days
Primary Outcome Measure Information:
Title
Clinical cure rate
Description
Clinical cure rate is defined as Total Severity Score (TSC) ≤ 2
Time Frame
Control 1 at day 4 after therapy end
Secondary Outcome Measure Information:
Title
Microbiological cure rate
Description
Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture
Time Frame
Control 1 at 4 days after therapy end
Title
Therapeutic cure rate
Description
Clinically and microbiologically cured
Time Frame
Control 1 at 4 days after therapy end
Title
Individual clinical signs and symptoms
Description
4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation
Time Frame
Control 1 at 4 days after therapy end
Title
Presence of dyspareunia
Description
yes/no
Time Frame
Control 1 at 4 days after therapy end
Title
Direct microscopy (wet smear)
Description
Presence or absence of Candida hyphea or spores
Time Frame
Control 1 at 4 days after therapy end
Title
vaginal pH
Time Frame
Control 1 at 4 days after therapy end
Title
Candida culture
Description
positive / negative for Candida spp
Time Frame
Control 1 at 4 days after therapy end
Title
Global assessment of efficacy
Description
4-point rating scale assessed by investigator and patient
Time Frame
Control 1 at 4 days after therapy end
Title
Patient Satisfaction
Description
presence of vaginal discomfort, increased discharge, burning sensation
Time Frame
Control 1 at 4 days after therapy end
Title
Adverse event
Description
Number of participants experiencing an adverse event
Time Frame
Control 1 at 4 days after therapy end
Title
Global assessment of tolerability
Description
4-point rating scale by investigator and patient
Time Frame
Control 1 at 4 days after therapy end
Title
Clinical cure rate
Description
Clinical cure rate defined as Total Symptom Score TSC ≤ 2
Time Frame
Control 2 at 6 weeks after therapy end
Title
Presence of external dysuria
Description
yes/no
Time Frame
Control 1 at 4 days after therapy end
Title
Microbiological cure rate
Description
Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture
Time Frame
Control 2 at 6 weeks after therapy end
Title
Therapeutic cure rate
Description
Clinically and microbiologically cured
Time Frame
Control 2 at 6 weeks after therapy end
Title
Individual clinical signs and symptoms
Description
4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation
Time Frame
Control 2 at 6 weeks after therapy end
Title
Presence of dyspareunia
Description
yes/no
Time Frame
Control 2 at 6 weeks after therapy end
Title
Direct microscopy (wet smear)
Description
Presence or absence of Candida hyphea or spores
Time Frame
Control 2 at 6 weeks after therapy end
Title
vaginal pH
Time Frame
Control 2 at 6 weeks after therapy end
Title
Candida culture
Description
positive / negative for Candida spp
Time Frame
Control 2 at 6 weeks after therapy end
Title
Global assessment of efficacy
Description
4-point rating scale assessed by investigator and patient
Time Frame
Control 2 at 6 weeks after therapy end
Title
Patient Satisfaction
Description
presence of vaginal discomfort, increased discharge, burning sensation
Time Frame
Control 2 at 6 weeks after therapy end
Title
Adverse event
Description
Number of participants experiencing an adverse event
Time Frame
Control 2 at 6 weeks after therapy end
Title
Global assessment of tolerability
Description
4-point rating scale by investigator and patient
Time Frame
Control 2 at 6 weeks after therapy end
Title
Presence of external dysuria
Description
yes/no
Time Frame
Control 2 at 6 weeks after therapy end

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manopchai Thamkhantho, Prof MD
Organizational Affiliation
Siriraj Gynaecologic ID and Female STD Unit, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
State/Province
Bangkok Noi district
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
32940765
Citation
Thamkhantho M, Chayachinda C. Vaginal tablets of dequalinium chloride 10 mg versus clotrimazole 100 mg for vaginal candidiasis: a double-blind, randomized study. Arch Gynecol Obstet. 2021 Jan;303(1):151-160. doi: 10.1007/s00404-020-05784-z. Epub 2020 Sep 17.
Results Reference
derived

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

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