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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: Fluomizin vaginal tablets
* Drug: Canesten vaginal tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluomizin vaginal tablets<br>Fluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7 | Drug: Fluomizin vaginal tablets<br>* One vaginal tablet for 6 days and 1 placebo tablet on day 7<br>* Other names: Naxyl vaginal tablets;|
| Active Comparator: Canesten vaginal tablets<br>Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days | Drug: Canesten vaginal tablets<br>* one vaginal tablet for 7 days<br>* Other names: 100mg clotrimazole vaginal tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate | 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 | 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 | Clinically and microbiologically cured | Control 1 at 4 days after therapy end | 
| 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 | Control 1 at 4 days after therapy end | 
| Presence of dyspareunia | yes/no | Control 1 at 4 days after therapy end | 
| Direct microscopy (wet smear) | Presence or absence of Candida hyphea or spores | Control 1 at 4 days after therapy end | 
| vaginal pH |  | Control 1 at 4 days after therapy end | 
| Candida culture | positive / negative for Candida spp | Control 1 at 4 days after therapy end | 
| Global assessment of efficacy | 4-point rating scale assessed by investigator and patient | Control 1 at 4 days after therapy end | 
| Patient Satisfaction | presence of vaginal discomfort, increased discharge, burning sensation | Control 1 at 4 days after therapy end | 
| Adverse event | Number of participants experiencing an adverse event | Control 1 at 4 days after therapy end | 
| Global assessment of tolerability | 4-point rating scale by investigator and patient | Control 1 at 4 days after therapy end | 
| Clinical cure rate | Clinical cure rate defined as Total Symptom Score TSC ≤ 2 | Control 2 at 6 weeks after therapy end | 
| Presence of external dysuria | yes/no | Control 1 at 4 days after therapy end | 
| Microbiological cure rate | 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 | Clinically and microbiologically cured | Control 2 at 6 weeks after therapy end | 
| 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 | Control 2 at 6 weeks after therapy end | 
| Presence of dyspareunia | yes/no | Control 2 at 6 weeks after therapy end | 
| Direct microscopy (wet smear) | Presence or absence of Candida hyphea or spores | Control 2 at 6 weeks after therapy end | 
| vaginal pH |  | Control 2 at 6 weeks after therapy end | 
| Candida culture | positive / negative for Candida spp | Control 2 at 6 weeks after therapy end | 
| Global assessment of efficacy | 4-point rating scale assessed by investigator and patient | Control 2 at 6 weeks after therapy end | 
| Patient Satisfaction | presence of vaginal discomfort, increased discharge, burning sensation | Control 2 at 6 weeks after therapy end | 
| Adverse event | Number of participants experiencing an adverse event | Control 2 at 6 weeks after therapy end | 
| Global assessment of tolerability | 4-point rating scale by investigator and patient | Control 2 at 6 weeks after therapy end | 
| Presence of external dysuria | yes/no | Control 2 at 6 weeks after therapy end | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vulvovaginal candidiasis, vulvovaginal candidosis, mycotic vaginal infection, dequalinium chloride, Fluomizin, clotrimazole, canesten