Efficacy and Safety of a Plasma Vaginal Cleanser (WOMEN CARE®) Using Plasma-Activated Water in Suspected Vaginitis: A Multicenter Randomized Clinical Trial

초록

Background/Objectives: Vaginitis is a prevalent inflammatory disorder of the vaginal mucosa, frequently arising from its anatomical proximity to the anorectal region and a microenvironment conducive to pathogen colonization and dysbiosis. This prospective, multicenter, randomized, third-party-blinded study assessed the efficacy and safety of a plasma vaginal cleanser (WOMEN CARE®) employing plasma-activated water (PAW) as a non-pharmacological alternative to conventional antimicrobials for restoring vaginal homeostasis. Methods: Women aged ≥19 years with clinically suspected vaginitis were assigned to either the experimental group (WOMEN CARE®) or the control group (standard pharmacotherapy). The primary endpoint was the proportion of participants exhibiting decreased Nugent scores between baseline and Visit 4. Results: Of 144 participants in the experimental group, 125 completed the study. The experimental group showed comparable outcomes to standard pharmacotherapy group across Nugent scores, vaginal pH, and symptoms severity, with pathogen suppression confirmed as non-inferior. Additionally, PAW exerted anti-HPV activity through a potential effect against new genotypic HPV infection. While the control group experienced antibiotic-associated adverse effects (e.g., headache, abdominal discomfort, nausea), no treatment-related adverse events occurred in the WOMEN CARE® group. Conclusions: These results indicate that PAW vaginal cleansing provides an effective, safe, non-antibiotic approach for managing vaginitis and maintaining vaginal ecological balance.

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