Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis
- Conditions
- Vulvovaginal Candidiasis
- Interventions
- Device: LactiSal vaginal tablet 50mgDevice: LactiSal vaginal gel 1%
- Registration Number
- NCT02907307
- Lead Sponsor
- Medinova AG
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LactiSal vaginal tablet 50 mg LactiSal vaginal tablet 50mg 50 mg of LactiSal vaginal tablet daily for 6 days Clotrimazole vaginal tablet 100mg Clotrimazole vaginal tablet 100mg 100 mg Clotrimazole vaginal tablet daily for 6 days LactiSal vaginal gel 1% LactiSal vaginal gel 1% 5g of 1%LactiSal Gel vaginal gel once daily for 6 days
- Primary Outcome Measures
Name Time Method Clinical cure rate 10 days after entry (C1) 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.
- Secondary Outcome Measures
Name Time Method Patient's satisfaction 10 days after entry visit and 4 weeks after control visit 1 Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions.
The Total Severity Score (TSC) Individual clinical signs and symptoms 10 days after entry visit and 4 weeks after control visit 1 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)Direct microscopy (Wet smear) 10 days after entry visit and 4 weeks after control visit 1 Number of positive findings in Direct microscopy (Wet smear) in comparison to visit E
pH 10 days after entry visit and 4 weeks after control visit 1 Mean vaginal pH in comparison to visit E
Candida culture 10 days after entry visit and 4 weeks after control visit 1 Number of positive Candida cultures in comparison to visit E
Microbiological cure rate 10 days after entry visit and 4 weeks after control visit 1 Negative for Candida in microscopy and culture
Clinical cure rate 4 weeks after control visit 1 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.
Therapeutic cure rate 10 days after entry visit and 4 weeks after control visit 1 Clinically and microbiologically cure combined
Dyspareunia and external dysuria 10 days after entry visit and 4 weeks after control visit 1 Presence of dyspareunia and external dysuria (yes/no)
Efficacy assessment 10 days after entry visit and 4 weeks after control visit 1 Global assessment of efficacy by patient and investigator
Patients diary 10 days after entry visit and 4 weeks after control visit 1 Assessment clinical symptoms from patient?s diary