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

Sponsor

Medinova AG (Industry)

Overall Status

Completed

CT.gov ID

NCT02242695

Collaborator

Mahidol University (Other)

150

Enrollment

Location

Arms

Duration (Months)

8.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vulvovaginal Candidiasis	Drug: Fluomizin vaginal tablets Drug: Canesten vaginal tablets	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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	Drug: Fluomizin vaginal tablets 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	Drug: Canesten vaginal tablets one vaginal tablet for 7 days Other Names: 100mg clotrimazole vaginal tablets

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

Drug: Fluomizin vaginal tablets

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

Drug: Canesten vaginal tablets

one vaginal tablet for 7 days

Other Names:

100mg clotrimazole vaginal tablets

Outcome Measures

Primary Outcome Measures

Clinical cure rate [Control 1 at day 4 after therapy end]
Clinical cure rate is defined as Total Severity Score (TSC) ≤ 2

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok	Bangkok Noi district	Thailand	10700