Open-label, Uncontrolled Clinical Research Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
The objective of this study is to determine clinical cure rate and safety of a proprietary Vaginal Cooling Device (VCD) in women with VCC. In addition, the safety, mycological cure rates, the speed and efficacy of symptom resolution, vaginal hyphae and polymorphonuclear (PMN) scores, and Quality-of-Life (QoL) parameters will be determined.
• Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the inclusion criteria.
‣ Women between 22-49 years of age and not more than one year since last menses, with the suspected diagnosis of uncomplicated VVC.
⁃ Able to read and understand English.
⁃ Able to provide written informed consent and to understand and agree to all study procedures required.
⁃ Has a smart phone and has the ability to access and use the ValidCare app.
⁃ Documented Papanicolaou (Pap) test at baseline or during the previous 12 months reported as either negative for intraepithelial lesion or malignancy or ASCUS-atypical squamous cells of undetermined significance and negative for high-risk HPV types or negative colposcopy plus/minus biopsies were performed for high-risk HPV types.
⁃ Clinical diagnosis of symptomatic VVC confirmed by positive KOH wet mount and yeast culture at baseline.
⁃ Presence of at least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation) of VVC.
⁃ Presence of at least one vulvovaginal symptom (itching, pain or burning, irritation)
⁃ Willing and able to avoid vaginal (or any) sexual activity during the study period.
‣ Menstrual products such as tampons, pads, and menstrual cups may be used during the study period including before and after device use.