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

Inclusion Criteria:

• Site investigators will evaluate the eligibility of women presenting with symptomsconsistent with VVC based on the inclusion criteria.

1. Women between 22-49 years of age and not more than one year since last menses,with the suspected diagnosis of uncomplicated VVC.

2. Able to read and understand English.

3. Able to provide written informed consent and to understand and agree to allstudy procedures required.

4. Has a smart phone and has the ability to access and use the ValidCare app.

5. Documented Papanicolaou (Pap) test at baseline or during the previous 12 monthsreported as either "negative for intraepithelial lesion or malignancy" or "ASCUS-atypical squamous cells of undetermined significance" and negative forhigh-risk HPV types or negative colposcopy plus/minus biopsies were performedfor high-risk HPV types.

6. Clinical diagnosis of symptomatic VVC confirmed by positive KOH wet mount andyeast culture at baseline.

7. Presence of at least one vulvovaginal sign (vulvovaginal erythema, edema, orexcoriation) of VVC.

8. Presence of at least one vulvovaginal symptom (itching, pain or burning,irritation)

9. Willing and able to avoid vaginal (or any) sexual activity during the studyperiod.

10. Menstrual products such as tampons, pads, and menstrual cups may be used duringthe study period including before and after device use.

Exclusion Criteria:

• 1. Site investigators will evaluate the eligibility of women presenting withsymptoms consistent with VVC based on the exclusion criteria.

2. Subject does not have a smart phone. 3. Subject does not have the ability toaccess and use the Validcare app. 4. Subjects who were treated for VVC within thepast 14 days. 5. Use of systemic, topical (applied to the vulva) or vaginalantibiotics, anti-fungal or anti-trichomonas drugs within 14 days.

3. Use of any systemic corticosteroid, immunosuppressive, or immune-stimulating drugwithin 3 months.

4. History of douching within the previous 7 days. 8. Urinary tract infection. 9.Unable or unwillingness to use tampons in the past. 10. Unable to maintain studyprotocol including but not limited to the avoidance of sexual activity during the 28days or time interval up to the assessment of the primary endpoint. This is neededto avoid reinfection, worsening of symptoms or new pathogen infection, whileassessing the efficacy of the subject device in treating the primary infection.

5. Use of anticoagulation therapy (e.g., warfarin, heparin). 12. Diabetes mellitus.

6. History of vulvodynia, vestibulitis, vaginismus, radiation-induced vaginitis, orpostmenopausal atrophy.

7. Immune compromised states such as HIV/AIDS or transplant subjects. 15. Subjectswith other infectious causes of vulvovaginitis or with mixed infections diagnosed atbaseline. (Note: if any trichomonad trophozoites are seen on wet smear on theinitial visit, the subject is to be excluded from the study.) 16. Symptomatic vulvaror vaginal condyloma or presence of another vaginal or vulvar condition that wouldconfound the interpretation of clinical response.

8. Pregnancy. 18. Presence of trichomonad trophozoites on wet smear at the initialvisit. 19. Any condition which, in the opinion of the investigator, should precludeparticipation in the study. If so, the investigator will collect information on thesubjects who are determined to have a condition that precludes participation in thestudy and the reasons for their exclusion documented within the DDCS to ensure thereis no bias introduced.