efficacy, safety lactisal 1% gel, lactsal 50 mg, clotrimazole 100 mg tablet in treatment vulvovaginal candidiasis

Conditions: Vulvovaginal Candidiasis

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)

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.

Eligibility criteria:
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.

Keywords: lactisal vaginal therapy