NCT06983041

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started May 2025

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
May 2025Jun 2026

First Submitted

Initial submission to the registry

May 2, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

May 22, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

May 2, 2025

Last Update Submit

January 28, 2026

Conditions

Vulvovaginal Candidiasis (VVC)Yeast Vaginitis

Keywords

yeast infection

Outcome Measures

Primary Outcomes (1)

  • Number of clinical cures at 7 days

    VSS of 0-1(based on severity of infection), KOH negative for Hyphae

    7 days (+/-2)

Secondary Outcomes (1)

  • Clinical Cure

    28 days (+/-2)

Other Outcomes (6)

  • Mycological Cure

    7 days (+/-2)

  • Mycological Cure

    28 days (+/- 2)

  • Polymorphonuclear Neutrophils (PMN)

    7 days (+/-2)

  • +3 more other outcomes

Study Arms (1)

uncomplicated vulvovaginal candidiasis

OTHER

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

Interventions

vaginal cooling deviceDEVICE

medical grade polymer capsule filled with inert fluid (15 cc's)

uncomplicated vulvovaginal candidiasis

Eligibility Criteria

Age22 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \. 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.
  • \. Use of any systemic corticosteroid, immunosuppressive, or immune-stimulating drug within 3 months.
  • \. 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.
  • \. Use of anticoagulation therapy (e.g., warfarin, heparin). 12. Diabetes mellitus. 13. History of vulvodynia, vestibulitis, vaginismus, radiation-induced vaginitis, or postmenopausal atrophy.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Symphony Clinical Research

Jacksonville, Florida, 32224, United States

RECRUITING

Nova Clinical Research

Miami, Florida, 33162, United States

RECRUITING

Pivotal Clinical Research & Associates

Smyrna, Georgia, 30082, United States

RECRUITING

Renew Health Clinical Research

Snellville, Georgia, 30078, United States

RECRUITING

Leavitt Clinical Research

Idaho Falls, Idaho, 83404, United States

SUSPENDED

Next Innovative Clinical Research

Chicago, Illinois, 60616, United States

RECRUITING

Unified Women's Clinical Research-Raleigh

Raleigh, North Carolina, 27607, United States

RECRUITING

Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Aviati Health

Memphis, Tennessee, 38115, United States

ACTIVE NOT RECRUITING

Vilo Research Group, Inc.

Houston, Texas, 77070, United States

RECRUITING

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsVulvovaginitisVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVulvitisVulvar DiseasesGenital Diseases

Central Study Contacts

Kimberly J Langdon, MD

CONTACT

740-206-4287kim@coologics.com

Keith Aqua, MD

CONTACT

561-951-8212kaqua@acrcfl.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 21, 2025

Study Start

May 22, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(10)