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

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)

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)

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.

Inclusion Criteria:

1. 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).

2. Direct microscopy (Wet smear) positive for yeast forms (hyphae, pseudohyphae) or budding yeasts

3. Normal vaginal pH (≤4.5)

4. Age: 18 years and older

5. 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.