Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of LactiSal 1%vaginal gel and LactiSal 50 mg vaginal tablet with the standart treatment of clotrimazole 100 mg vaginal tablet in woman with vulvovaginal candidiasis (VVC)

Detailed Description
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National multicenter,randomized, open-label, active-controlled with three parallel groups.Eligible patients are randomized to receive LactiSal 1% vaginal gel, LactiSal 50 mg vaginal tablet or clotrimazole 100 mg vaginal tablet for 6 days. Control examaminations are performed 10 after entry and 4 weeks after control visit 1. The study investigates the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50mg vaginal tablets in the intended use, i.e. vaginal application, and the following intended claims: Treatment of vaginal yeast vaginitis Relieves vaginal itching, burning, redness and discharge in case of yeast vaginitis Inhibition of yeast colonization in the vagina in case of yeast vaginitis. The study is designed to compare the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50 mg vaginal tablets to a current standard drug therapy, i.e. clotrimazole 100 mg vaginal tablets. While LactiSal is classified as medical device class IIa, the comparator is a medicinal (pharmaceutical) product. The study represents a mixed study, comparing the efficacy of a medical device with a pharmaceutical product.

Official Title
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Comparative Study of the Efficacy and Safety of LactiSal 1% Vaginal Gel and LactSal 50 mg Vaginal Tablet Versus Clotrimazole 100 mg Vaginal Tablet in the Treatment of Vulvovaginal Candidiasis (VVC)

Conditions
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Vulvovaginal Candidiasis

Intervention / Treatment
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* Device: LactiSal vaginal gel 1%
* Device: LactiSal vaginal tablet 50mg
* Drug: Clotrimazole vaginal tablet 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical signs & symptoms of VVC as Total Severity Score, TSC 4 (range 0-15): vaginal itching (range 0-3) , vaginal burning or soreness (range 0-3), abnormal vaginal discharge (range 0-3), vulvo/vaginal erythema or oedema (range 0-3), vulvar excoriation or fissure formation (range 0-3). Direct microscopy (Wet smear) positive for yeast forms (hyphae, pseudohyphae) or budding yeasts Normal vaginal pH (≤4.5) Age: 18 years and older Signed Written Informed Consent to participate in this study. Exclusion Criteria: Recurrent VVC (4 episodes of VVC in the past 12 months). Women with other vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections. Women using oral or vaginal antifungals within 2 weeks prior to enrolment. Women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment. Women using any antibiotic or anti-infective within 2 weeks prior to enrolment. Women having menstruation bleeding at enrolment Cervicitis, cervical erosions, and malignant tumours in the genital tract Pregnancy or lactation. Women not consenting to be sexually abstinent during the treatment, not taking oral contraceptive or not having an IUD for contraception Woman using intravaginal pessaries, rings, sponges or diaphragms Severe systemic diseases (diabetes mellitus, cancer, tuberculosis, autoimmune diseases, severe psychiatric conditions, etc.). Women with confirmed or suspected STD (HIV infection, gonorrhoea, syphilis, chlamydiasis, etc.). Known or suspected hypersensitivity to one of the study medications, inclusive their excipients. Participation of patient in another clinical study concomitantly or within 30 days prior to enrolment Patient is relative of, or staff directly reporting to, the investigator.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LactiSal vaginal gel 1%<br>5g of 1%LactiSal Gel vaginal gel once daily for 6 days | Device: LactiSal vaginal gel 1%<br>* to be administered daily intravaginally for 6 days<br>|
| Experimental: LactiSal vaginal tablet 50 mg<br>50 mg of LactiSal vaginal tablet daily for 6 days | Device: LactiSal vaginal tablet 50mg<br>* to be administered daily intravaginally for 6 days<br>|
| Active Comparator: Clotrimazole vaginal tablet 100mg<br>100 mg Clotrimazole vaginal tablet daily for 6 days | Drug: Clotrimazole vaginal tablet 100mg<br>* to be administered daily intravaginally for 6 days<br>* Other names: Candibene;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate | Clinical cure is defined as patient having a Total Severity Score of less than 3. The Total Severity Score (TSC) is assessed by the Investigator, examining and interviewing the patient. The TSC is the sum score of the 5 individual signs symptoms - vaginal itching, vaginal burning or soreness, abnormal vaginal discharge, vulvovaginal erythema or oedema and vulval excoriation or fissure formation. Each sign and symptom is assessed with a score from 0 to 3, resulting in total score for TSC of 0 to 15. | 10 days after entry (C1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate | Clinical cure is defined as patient having a Total Severity Score of less than 3. The Total Severity Score (TSC) is assessed by the Investigator, examining and interviewing the patient. The TSC is the sum score of the 5 individual signs symptoms - vaginal itching, vaginal burning or soreness, abnormal vaginal discharge, vulvovaginal erythema or oedema and vulval excoriation or fissure formation. Each sign and symptom is assessed with a score from 0 to 3, resulting in total score for TSC of 0 to 15. | 4 weeks after control visit 1 | 
| Microbiological cure rate | Negative for Candida in microscopy and culture | 10 days after entry visit and 4 weeks after control visit 1 | 
| Therapeutic cure rate | Clinically and microbiologically cure combined | 10 days after entry visit and 4 weeks after control visit 1 | 
| The Total Severity Score (TSC) Individual clinical signs and symptoms | The TCS assessed by the investigator vaginal itching (range 0-3) vaginal burning or soreness (range 0-3) abnormal vaginal discharge (range 0-3) vulvo/vaginal erythema or oedema (range 0-3) vulvar excoriation or fissure formation (range 0-3) | 10 days after entry visit and 4 weeks after control visit 1 | 
| Dyspareunia and external dysuria | Presence of dyspareunia and external dysuria (yes/no) | 10 days after entry visit and 4 weeks after control visit 1 | 
| Direct microscopy (Wet smear) | Number of positive findings in Direct microscopy (Wet smear) in comparison to visit E | 10 days after entry visit and 4 weeks after control visit 1 | 
| pH | Mean vaginal pH in comparison to visit E | 10 days after entry visit and 4 weeks after control visit 1 | 
| Candida culture | Number of positive Candida cultures in comparison to visit E | 10 days after entry visit and 4 weeks after control visit 1 | 
| Efficacy assessment | Global assessment of efficacy by patient and investigator | 10 days after entry visit and 4 weeks after control visit 1 | 
| Patients diary | Assessment clinical symptoms from patient?s diary | 10 days after entry visit and 4 weeks after control visit 1 | 
| Patient's satisfaction | Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions. | 10 days after entry visit and 4 weeks after control visit 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LactiSal, Vaginal therapy