Actively Recruiting
Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
Led by Coologics, Inc · Updated on 2026-01-30
55
Participants Needed
10
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 and not more than one year since last menstrual period with suspected uncomplicated VVC
- Able to read and understand English
- Able to provide written informed consent and agree to all study procedures
- Have a smartphone and can access and use the ValidCare app
- Documented Pap test at baseline or within the past 12 months showing negative or ASCUS results and negative for high-risk HPV or negative colposcopy
- Clinical diagnosis of symptomatic VVC confirmed by positive KOH wet mount and yeast culture at baseline
- Presence of at least one vulvovaginal sign such as erythema, edema, or excoriation
- Presence of at least one vulvovaginal symptom like itching, pain, burning, or irritation
- Willing and able to avoid vaginal or any sexual activity during the study period
- Allowed to use menstrual products such as tampons, pads, or menstrual cups during the study
You will not qualify if you...
- No smartphone or inability to use the ValidCare app
- Treated for VVC within the past 14 days
- Use of systemic, topical vulvar, or vaginal antibiotics, antifungals, or anti-trichomonas drugs within 14 days
- Use of systemic corticosteroids, immunosuppressive, or immune-stimulating drugs within 3 months
- History of douching within the previous 7 days
- Current urinary tract infection
- Unable or unwilling to use tampons
- Unable to follow study protocol including avoidance of sexual activity during the 28-day study period
- Use of anticoagulation therapy such as warfarin or heparin
- Diabetes mellitus
- History of vulvodynia, vestibulitis, vaginismus, radiation-induced vaginitis, or postmenopausal atrophy
- Immune-compromised conditions such as HIV/AIDS or transplant recipients
- Other infectious vulvovaginitis or mixed infections diagnosed at baseline
- Symptomatic vulvar or vaginal condyloma or other vaginal/vulvar conditions that could affect clinical response
- Pregnancy
- Presence of trichomonad trophozoites on initial wet smear
- Any condition that investigators determine would preclude participation
AI-Screening
AI-Powered Screening
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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
CONTACT
K
Keith Aqua, MD
CONTACT
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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