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

Phase 4

Completed

• Conditions: Vulvovaginal Candidiasis
• Interventions: Drug: Fluomizin vaginal tablets; Drug: Canesten vaginal tablets

• Registration Number: NCT02242695
• Lead Sponsor: Medinova AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-17
• Study Start: 2014-11
• Status Verified: 2015-07
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluomizin vaginal tablets	Fluomizin vaginal tablets	Fluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7
Canesten vaginal tablets	Canesten vaginal tablets	Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Global assessment of tolerability	Control 2 at 6 weeks 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 2 at 6 weeks after therapy end	yes/no
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

Trial Locations

Locations (1)

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