Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22-49
SponsorCoologics, Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the inclusion criteria.
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.
Disqualifiers
1. Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the exclusion criteria.
Trial design
Design model
Single group
Treatments tested in this trial
vaginal cooling device
Devicemedical grade polymer capsule filled with inert fluid (15 cc's)
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: uncomplicated vulvovaginal candidiasisOther 1 intervention
Trial outcomes
Primary outcomes
1
Number of clinical cures at 7 days
VSS of 0-1(based on severity of infection), KOH negative for Hyphae
Time frame
7 days (+/-2)Secondary outcomes
1
Clinical Cure
VSS of 0-1(based on severity of infection), KOH negative for Hyphae
Time frame
28 days (+/-2)Other outcomes
1
Mycological Cure
Negative fungal culture for offending species
Time frame
7 days (+/-2)2
Mycological Cure
Negative fungal culture for offending species
Time frame
28 days (+/- 2)3
Polymorphonuclear Neutrophils (PMN)
Quantification of PMNs
Time frame
7 days (+/-2)4
Polymorphonuclear Neutrophils (PMN)
Quantification of PMNs
Time frame
28 days (+/- 2)Sponsors and contacts
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Source ClinicalTrials.gov