Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)

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)