NCT06985433

Light Treatment of Vaginal Infections in Reproductive Age Women

Light Treatment of Symptomatic Vulvovaginitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: UVISA Health ApS · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Antimicrobials have helped in managing vaginal dysbiotic conditions such as bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC). However, their increasing inefficiency and rise in antimicrobial resistance (AMR) is a challenge and threat to public health. Therefore, this study will investigate the safety and efficacy of light as an antimicrobial to treat vulvovaginal infections.

Detailed description

Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) are two of the most common vaginal infections, affecting millions of women worldwide. These infections can cause significant discomfort, reduced quality of life, and, in some cases, negative reproductive outcomes. Despite their prevalence, challenges remain in accurate diagnosis, effective treatment, and long-term management, highlighting the need for new treatment methods and solid clinical evidence. BV occurs when there is an imbalance in the normal vaginal microbiota with symptoms of vaginal discharge and irritation. BV also increases the risk of sexually transmitted infections and negative pregnancy outcomes. Treatments with antibiotics have varying effectiveness and high recurrence rates. VVC is caused by an overgrowth of Candida albicans and presents as itching, burning, and thick, cottage cheese-like discharge. Although antifungal medications are often effective, recurrent VVC (RVVC) is a significant challenge requiring long-term treatment. There is also a risk of resistance to antibiotic and antifungal medications. Self-diagnosis and self-treatment are common, which can lead to misdiagnosis and ineffective treatment. Overuse of antimicrobial medications can cause side effects and resistance. Therefore, there is a need for new treatment methods to improve patient outcomes and quality of life. This clinical trial represents a first in human pilot, efficacy study of the effectiveness of vaginal light therapy in women with BV and/or VVC. The study will also evaluate the safety and tolerability of the treatment, as well as examine the underlying vaginal microbial dynamics.

Conditions

• Bacterial Vaginosis
• Vulvovaginal Candidiases

Interventions

Type	Name	Description
DEVICE	Vaginal light therapy - Once	Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in single treatment session.
DEVICE	Vaginal Light Therapy - Once	Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in single treatment session.
DEVICE	Vaginal Light Therapy - Twice	Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in two treatment sessions.
DEVICE	Vaginal Light Therapy - Twice	Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in two treatment sessions.

Timeline

• Start date: 2025-06-05
• Primary completion: 2025-12-29
• Completion: 2026-02-02
• First posted: 2025-05-22
• Last updated: 2026-02-17

Locations

1 site across 1 country: Denmark