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Volume 13
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10.3390/biomedicines13123076
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

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

by
Hye-Jin Cho
1,
Min-Kyeong Kim
1,
Yun-Seo Choe
2,
Seo-Yeon Son
1,
Chi-Gu Kang
3,
So-Jung Lim
3,
Sooyong Kim
4,
Hoonseong Choi
4,
Un Suk Jung
5 and
Ju-Seop Kang
3,*
1
Honest Women’s Clinic, Seoul 07333, Republic of Korea
2
ON Women’s Clinic, Seoul 04571, Republic of Korea
3
Department of Pharmacology, College of Medicine, Hanyang University, Seoul 04763, Republic of Korea
4
Corporate Research Institute, 4Hglobal, Bucheon 14559, Republic of Korea
5
Department of Obstetrics and Gynecology, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri 11923, Republic of Korea
*
Author to whom correspondence should be addressed.
Biomedicines 2025, 13(12), 3076; https://doi.org/10.3390/biomedicines13123076 (registering DOI)
Submission received: 30 September 2025 / Revised: 1 December 2025 / Accepted: 11 December 2025 / Published: 12 December 2025
(This article belongs to the Section Molecular and Translational Medicine)
Versions Notes

Abstract

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.
Keywords: vaginitis; plasma-activated water (PAW); WOMEN CARE®; vaginal microbiota; Nugent score; non-antibiotic therapy vaginitis; plasma-activated water (PAW); WOMEN CARE®; vaginal microbiota; Nugent score; non-antibiotic therapy

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MDPI and ACS Style

Cho, H.-J.; Kim, M.-K.; Choe, Y.-S.; Son, S.-Y.; Kang, C.-G.; Lim, S.-J.; Kim, S.; Choi, H.; Jung, U.S.; Kang, J.-S. Efficacy and Safety of a Plasma Vaginal Cleanser (WOMEN CARE®) Using Plasma-Activated Water in Suspected Vaginitis: A Multicenter Randomized Clinical Trial. Biomedicines 2025, 13, 3076. https://doi.org/10.3390/biomedicines13123076

AMA Style

Cho H-J, Kim M-K, Choe Y-S, Son S-Y, Kang C-G, Lim S-J, Kim S, Choi H, Jung US, Kang J-S. Efficacy and Safety of a Plasma Vaginal Cleanser (WOMEN CARE®) Using Plasma-Activated Water in Suspected Vaginitis: A Multicenter Randomized Clinical Trial. Biomedicines. 2025; 13(12):3076. https://doi.org/10.3390/biomedicines13123076

Chicago/Turabian Style

Cho, Hye-Jin, Min-Kyeong Kim, Yun-Seo Choe, Seo-Yeon Son, Chi-Gu Kang, So-Jung Lim, Sooyong Kim, Hoonseong Choi, Un Suk Jung, and Ju-Seop Kang. 2025. "Efficacy and Safety of a Plasma Vaginal Cleanser (WOMEN CARE®) Using Plasma-Activated Water in Suspected Vaginitis: A Multicenter Randomized Clinical Trial" Biomedicines 13, no. 12: 3076. https://doi.org/10.3390/biomedicines13123076

APA Style

Cho, H.-J., Kim, M.-K., Choe, Y.-S., Son, S.-Y., Kang, C.-G., Lim, S.-J., Kim, S., Choi, H., Jung, U. S., & Kang, J.-S. (2025). Efficacy and Safety of a Plasma Vaginal Cleanser (WOMEN CARE®) Using Plasma-Activated Water in Suspected Vaginitis: A Multicenter Randomized Clinical Trial. Biomedicines, 13(12), 3076. https://doi.org/10.3390/biomedicines13123076

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