prof-001_phase iia

Conditions: Vulvovaginal Candidiasis (VVC)

Summary: this is a multi-center, randomized, prospective, active-controlled, double-blind, dose-escalation study comparing dose response of clinical efficacy, safety, local tolerability of three different doses of prof-001/candiplus® (candiplus® 0.2%, candiplus® with 0.3%, candiplus® with 0.4%) to 1% clotrimazole vaginal cream. patients with acute episode of vulvovaginal candidiasis (vvc) will be randomized to receive a daily dose of either 5 ml (intravaginal) of candiplus® at three different doses for the first 3 days and 2.5 ml for the remaining 3 days or 5 ml (intravaginal) application of 1% clotrimazole cream over the first 3 days and 2.5 ml for the remaining 3 days according to the following scheme (with each application 2 cm of cream will be applied to the vulvar region): cohort 1: candiplus® 0.2% versus clotrimazole mono cohort 2: candiplus® 0.3% versus clotrimazole mono cohort 3: candiplus® 0.4% versus clotrimazole mono randomization into the cohorts will occur consecutively from the lowest dose to the highest dose, i.e. patients will be randomized first in cohort 1 and finally in cohort 3. the proposed study is - after a pilot study to assess critical pharmacokinetic data - the second study within a clinical trial program with the objective to develop a new combination therapy for the treatment of vulvovaginal candidiasis. the new combination consists of two registered drug substances.


Eligibility criteria:
inclusion criteria: * premenopausal female patients ≥ 18 years old * patients suffering from an acute episode of vulvovaginal candidiasis, characterized by: * positive vaginal smear (native, koh) for budding yeasts and/or fungal (pseudo-) hyphae, normal or intermediate flora (g i and g ii) * positive clinical symptoms (itching, burning, irritation, edema, erythema, excoriations), with a subjective symptom score of at least 3 (0=absent, 1=mild, 2=moderate, and 3=severe), with score being at least moderate for at least 1 subjective symptom and itching being present, and a total sign and symptom score of at least 4 * readiness for sexual abstinence from start of treatment until test of cure (toc) - visit * sufficient knowledge of german language to understand trial instructions and rating scales, and ability to comply with treatment * written informed consent prior to enrolment exclusion criteria: * known hypersensitivity to any ingredient of the investigational medicinal product * pregnancy or breast feeding at time of screening * menstrual bleeding (spotting is not an exclusion criterion) during the first three days of treatment * acute cystitis * patients with clinical signs of other infectious causes of vulvovaginitis: bacterial vaginosis (giii), trichomonas vaginalis, herpes simplex genitalis * treatment with antimycotics (systemic or vaginal) within 7 days of randomization * chronic use of non-steroidal anti-inflammatory drugs (nsaids) * patients with other clinical gynecological abnormalities, such as infections of the upper urogenital tract (pelvic inflammatory disease, adnexitis) * subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response (e.g. lichen sclerosus, neuropathic pain) * subjects who will be under treatment or surgery for gynecological pathologies during the study period, i.e, cervical intraepithelial neoplasia, cervical carcinoma, other neoplasms * known alcohol, drug or medication abuse * any clinically relevant concomitant condition that could compromise the objectives of this study and/ or the patient's compliance (eg. known immune deficiency syndrome with clinical relevance at time of screening) * participation in another interventional clinical trial within the last 30 days * employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor

Keywords: vulvovaginal candidiasis candiplus clotrimazole safety tolerability clinical efficacy