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The Scientific Facts
The Journal of Infectious Diseases
Use of Intravaginal Cooling to Provide Symptom Relief in Women With Vulvovaginal Candidiasis and Reduce Immunopathology in an Accompanying Mouse Model
Background
Vulvovaginal candidiasis (VVC), caused primarily by Candida albicans, is treated with anti-fungal drugs, often with variable efficacy and relapses. New therapeutic strategies, including drug-free alternatives, are needed. Upon overgrowth or environmental triggers, C. albicans commensal yeast transitions into hyphae resulting in an aberrant immunopathologic neutrophil response that contributes to the characteristic signs and symptoms of vaginitis. The purpose of this study was to evaluate the efficacy of an intravaginal cooling device (Vlisse) in women with VVC to provide symptom relief via putative reversal of C. albicans hyphae to yeast, with additional proof of principle in an animal model.
Human Trial Data
Sarasota
Dr. Michael Swor-PI
IRB-Approved Trial (2016) N=5
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Moderate to Severe Infections
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FDA criteria for DX and F/U 5
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Clinical Cures/No rescue medication
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Faster symptom resolution than drugs
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One with BV/VVC*
Boynton Beach
Dr. Keith Aqua-PI
Investigator-Initiated Trial (2021) N=6
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FDA criteria for DX and F/U
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Three had VVC alone
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One had VVC/AV*
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One had VVC/AV/BV
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One had BV/AV
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6 clinical cures for all conditions/no rescue medication
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2 mycologic cures for Candida
Total: 30 Cures
19 More Users Cured
13 of those were MD/NP/PhD-Observed
One had BV with VVC-CURED
*VVC is Vulvovaginal Candidiasis
*BV is Bacterial Vaginosis
*AV is Aerobic Vaginitis
Importance of Mouse Data
*ALL drugs tested in the mouse model FAILED due to pH, favoring infection
Results
Two studies in mice (2018) were conducted at LSU (PhD Experts in VVC) Results establish:
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The mechanism of action
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Proof of cooling efficacy
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Statistically Significant reduction in inflammation (PMNs) or white blood cells: the immune response
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Statistically Significant reduction in infection (Hyphae)
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‘p‘ values less than 0.05 are statistically significant
Vlisse™ is a Class I Device in the European Union CE Mark Pending and a FDA Class II device pending FDA clearance.