Vaginal cooling device for treating vulvovaginal yeast infections

Open-label, Uncontrolled Clinical Research Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)

This tests a vaginal cooling device to see if it helps women aged 22–49 with vulvovaginal yeast infections feel better and clear the infection.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 22 Years to 49 Years
• Sex: Female
• Sponsor: Coologics, Inc (industry)
• Drugs / interventions: radiation
• Locations: 10 sites (Jacksonville, Florida and 9 other locations)
• Trial ID: NCT06983041 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls women with symptomatic uncomplicated vulvovaginal candidiasis confirmed by KOH wet mount and yeast culture to receive a proprietary vaginal cooling device. The study measures clinical cure and safety, plus mycological cure rates, speed of symptom relief, vaginal hyphae and polymorphonuclear (PMN) cell scores, and quality-of-life parameters. Participants must meet screening requirements including a recent normal Pap result and have a smartphone to use the study app. Study visits take place at selected clinical research sites in Florida and Georgia.

Who should consider this trial

Good fit: Ideal candidates are women aged 22–49 with acute uncomplicated VVC confirmed by positive KOH and yeast culture, a recent normal Pap result, and the ability to use the required smartphone app.

Not a fit: Patients who do not meet inclusion criteria — for example those outside the 22–49 age range, without confirmatory KOH/culture, or without smartphone/app access — are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the device could offer a non-drug option that speeds symptom relief and improves cure rates for uncomplicated VVC.

How similar studies have performed: Using local cooling as a treatment for vulvovaginal candidiasis is a novel approach with limited prior published evidence.

Eligibility criteria

Inclusion Criteria:

* Site investigators will evaluate the eligibility of women presenting with symptoms consistent 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 all study 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 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.
  6. Clinical diagnosis of symptomatic VVC confirmed by positive KOH wet mount and yeast culture at baseline.
  7. Presence of at least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation) 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 study period.
  10. Menstrual products such as tampons, pads, and menstrual cups may be used during the study period including before and after device use.

Exclusion Criteria:

* 1\. Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the exclusion criteria.

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

  6\. Use of any systemic corticosteroid, immunosuppressive, or immune-stimulating drug within 3 months.

  7\. 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 study protocol including but not limited to the avoidance of sexual activity during the 28 days or time interval up to the assessment of the primary endpoint. This is needed to avoid reinfection, worsening of symptoms or new pathogen infection, while assessing the efficacy of the subject device in treating the primary infection.

  11\. Use of anticoagulation therapy (e.g., warfarin, heparin). 12. Diabetes mellitus. 13. History of vulvodynia, vestibulitis, vaginismus, radiation-induced vaginitis, or postmenopausal atrophy.

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

  17\. Pregnancy. 18. Presence of trichomonad trophozoites on wet smear at the initial visit. 19. Any condition which, in the opinion of the investigator, should preclude participation in the study. If so, the investigator will collect information on the subjects who are determined to have a condition that precludes participation in the study and the reasons for their exclusion documented within the DDCS to ensure there is no bias introduced.

Where this trial is running

Jacksonville, Florida and 9 other locations

• Symphony Clinical Research — Jacksonville, Florida, United States (RECRUITING)
• Nova Clinical Research — Miami, Florida, United States (RECRUITING)
• Pivotal Clinical Research & Associates — Smyrna, Georgia, United States (RECRUITING)
• Renew Health Clinical Research — Snellville, Georgia, United States (RECRUITING)
• Leavitt Clinical Research — Idaho Falls, Idaho, United States (SUSPENDED)
• Next Innovative Clinical Research — Chicago, Illinois, United States (RECRUITING)
• Unified Women's Clinical Research-Raleigh — Raleigh, North Carolina, United States (RECRUITING)
• Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States (RECRUITING)
• Aviati Health — Memphis, Tennessee, United States (ACTIVE_NOT_RECRUITING)
• Vilo Research Group, Inc. — Houston, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Kimberly J Langdon, MD

Conditions: Vulvovaginal Candidiasis, Yeast Vaginitis, yeast infection