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

January 28, 2026 updated by: Coologics, Inc

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
      • Miami, Florida, United States, 33162
        • Recruiting
        • Nova Clinical Research
        • Contact:
        • Principal Investigator:
          • Christ-Ann Maglorie, MD
    • Georgia
      • Smyrna, Georgia, United States, 30082
        • Recruiting
        • Pivotal Clinical Research & Associates
        • Contact:
        • Principal Investigator:
          • Melinda Miller-Thrasher, MD
      • Snellville, Georgia, United States, 30078
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Suspended
        • Leavitt Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60616
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Unified Women's Clinical Research-Raleigh
        • Contact:
        • Principal Investigator:
          • Ann Collins, MD
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Lyndhurst Clinical Research
        • Contact:
        • Principal Investigator:
          • Robert Parker, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38115
        • Active, not recruiting
        • Aviati Health
    • Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: uncomplicated vulvovaginal candidiasis
Twice daily use of vaginal cooling device for 30 minutes a time for three days (i.e., 3 hours total) in female subjects with VVC age 22-49 (inclusive).
Device: vaginal cooling device
medical grade polymer capsule filled with inert fluid (15 cc's)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of clinical cures at 7 days
Time Frame: 7 days (+/-2)
VSS of 0-1(based on severity of infection), KOH negative for Hyphae
7 days (+/-2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Cure
Time Frame: 28 days (+/-2)
VSS of 0-1(based on severity of infection), KOH negative for Hyphae
28 days (+/-2)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mycological Cure
Time Frame: 7 days (+/-2)
Negative fungal culture for offending species
7 days (+/-2)
Mycological Cure
Time Frame: 28 days (+/- 2)
Negative fungal culture for offending species
28 days (+/- 2)
Polymorphonuclear Neutrophils (PMN)
Time Frame: 7 days (+/-2)
Quantification of PMNs
7 days (+/-2)
Polymorphonuclear Neutrophils (PMN)
Time Frame: 28 days (+/- 2)
Quantification of PMNs
28 days (+/- 2)
Hyphae Scores
Time Frame: 7 days (+/-2)
Quantification of Hyphae levels
7 days (+/-2)
Hyphae Scores
Time Frame: 28 days (+/- 2)
Quantification of Hyphae levels
28 days (+/- 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coologics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

May 2, 2025

First Submitted That Met QC Criteria

May 13, 2025

First Posted (Actual)

May 21, 2025

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00079644

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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