Clinical trial NCT06985433: Light Treatment of Vaginal Infections in Reproductive Age Women
Official title: Light Treatment of Symptomatic Vulvovaginitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bacterial Vaginosis
Vulvovaginal Candidiases
Lead sponsor: UVISA Health ApS
Sponsor class: INDUSTRY
Collaborators: name: Odense University Hospital
First posted: 2025-05-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 18-45 years of age
* Normal gynecological status
* Diagnosed for BV or VVC
* Not pregnant
* No signs of other genital tract infections

Exclusion Criteria:

* Current signs of other genital tract infection including STD
* Concomitant medication for treatment of vaginal infections or use of any intravaginal medication during the clinical investigation
* Pregnancy
* Current genital malignancies, chemotherapy for any reason within the last 6 months, previous radiotherapy in the genitourinary system. Cervical dysplasia diagnosis or treatment within the last 3 months (where applicable)

Primary outcomes:
measure: Patient reported reduction in symptoms of BV/VVC
timeFrame: Upto 2 months
Secondary outcomes:
measure: Clinical resolution of BV and/or VVC
timeFrame: Upto 2 months
measure: Healthier vaginal microbiome as compared to pre-treatment state.
timeFrame: Upto 2 months
measure: Vaginal health questionnaire
timeFrame: 2 Weeks
Other outcomes:
measure: No visual sign of tissue damage from light treatment.
timeFrame: Upto 2 months
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
References: