Actively Recruiting
Open-label Clinical Study of a Vaginal Cooling Device for Treating Vulvovaginal Candidiasis (VVC) in Women Ages 22 to 49
Led by Coologics, Inc · Updated on 2026-01-30
55
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical cure rate and safety of a specialized Vaginal Cooling Device (VCD) in women with uncomplicated vulvovaginal candidiasis (VVC), a yeast infection affecting the vagina. The study also aims to assess the safety, fungal cure rates, speed and effectiveness of symptom relief, vaginal hyphae and immune cell counts, as well as quality-of-life measures related to VVC. Participants will use the vaginal cooling device, which is a medical-grade polymer capsule filled with inert fluid, twice daily for 30 minutes each time over three days, totaling 3 hours of use. This open-label, uncontrolled study involves women aged 22 to 49 who have confirmed VVC. There is no placebo or comparison group, and the device use is monitored to evaluate its effects. Women in the study will undergo clinical diagnosis and confirmation of VVC by laboratory tests at baseline. Researchers will monitor the number of clinical cures at 7 days, with follow-up at 28 days to assess ongoing cure rates. Participants will avoid vaginal sexual activity during the study and use a smartphone app to support study procedures. Safety, symptom resolution, and quality-of-life changes will be closely tracked throughout the study period, which concludes by June 2026.
CONDITIONS
Brief Title
Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 22 to 49 years, no more than one year since last menses, with suspected uncomplicated vulvovaginal candidiasis (VVC)
- Able to read and understand English
- Able to provide written informed consent and agree to study procedures
- Owns a smartphone and can access and use the ValidCare app
- Has a documented Pap test within the past 12 months with negative or low-risk results
- Clinical diagnosis of symptomatic VVC confirmed by positive KOH wet mount and yeast culture
- Presence of at least one vulvovaginal sign such as redness, swelling, or skin irritation
- Presence of at least one symptom including itching, pain, burning, or irritation
- Willing and able to avoid vaginal sexual activity during the study period
- Permitted to use menstrual products such as tampons, pads, or cups during the study
You will not qualify if you...
- Does not own a smartphone or cannot use the ValidCare app
- Treatment for VVC within the past 14 days
- Use of systemic, topical vulvar, or vaginal antibiotics, antifungal, or anti-trichomonas drugs within 14 days
- Use of systemic corticosteroids, immunosuppressive, or immune-stimulating drugs within 3 months
- History of douching within 7 days prior to study
- Current urinary tract infection
- Unable or unwilling to use tampons
- Unable to follow study protocol, including avoiding sexual activity during the study
- Use of anticoagulation therapy such as warfarin or heparin
- Diabetes mellitus
- History of vulvodynia, vestibulitis, vaginismus, radiation-induced vaginitis, or postmenopausal atrophy
- Immunocompromised conditions such as HIV/AIDS or transplant
- Other infectious vulvovaginitis or mixed infections at baseline
- Symptomatic vulvar or vaginal condyloma or other confounding vaginal or vulvar conditions
- Pregnancy
- Presence of trichomonad trophozoites on initial wet smear
- Any condition deemed by the investigator to preclude participation
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 days
Participants use the vaginal cooling device twice daily for 30 minutes each time over three days.
6 device usage sessions (twice daily for 3 days)
Duration - 28 days (+/- 2 days)
Participants are assessed for clinical cure at approximately 7 days and again at 28 days after treatment.
2 follow-up assessments
Trial Site Locations
Total: 10 locations
1
Symphony Clinical Research
Jacksonville, Florida, United States, 32224
Actively Recruiting
2
Nova Clinical Research
Miami, Florida, United States, 33162
Actively Recruiting
3
Pivotal Clinical Research & Associates
Smyrna, Georgia, United States, 30082
Actively Recruiting
4
Renew Health Clinical Research
Snellville, Georgia, United States, 30078
Actively Recruiting
5
Leavitt Clinical Research
Idaho Falls, Idaho, United States, 83404
Suspended
6
Next Innovative Clinical Research
Chicago, Illinois, United States, 60616
Actively Recruiting
7
Unified Women's Clinical Research-Raleigh
Raleigh, North Carolina, United States, 27607
Actively Recruiting
8
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
9
Aviati Health
Memphis, Tennessee, United States, 38115
Active, Not Recruiting
10
Vilo Research Group, Inc.
Houston, Texas, United States, 77070
Actively Recruiting
Research Team
K
Kimberly J Langdon, MD
K
Keith Aqua, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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