A Phase IIa Randomized, Active-controlled, Double-blind, Dose-escalation Study in Patients With Vulvovaginal Candidiasis to Evaluate Dose Response Relationship of Clinical Efficacy, Safety and Tolerability of Topically Administered ProF-001

Date de début de l'étude : 4 avril 2017

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