Light Treatment of Vaginal Infections in Reproductive Age Women

NCT ID: NCT06985433

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2025-10-31

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.

Conditions

Bacterial Vaginosis; Vulvovaginal Candidiases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment of BV with single session of light treatment.

A group of 10 patients will receive light therapy in single treatment session to evaluate its safety and efficacy.

Group Type: EXPERIMENTAL

Vaginal light therapy - Once

Intervention Type: DEVICE

Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in single treatment session.

Treatment of BV with two sessions of light treatment.

A group of 10 patients will receive light therapy in two treatment sessions to evaluate its safety and efficacy.

Group Type: EXPERIMENTAL

Vaginal Light Therapy - Twice

Intervention Type: DEVICE

Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in two treatment sessions.

Treatment of VVC with single session of light treatment.

A group of 10 patients will receive light therapy in single treatment session to evaluate its safety and efficacy.

Group Type: EXPERIMENTAL

Vaginal Light Therapy - Once

Intervention Type: DEVICE

Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in single treatment session.

Treatment of VVC with two sessions of light treatment.

A group of 10 patients will receive light therapy in two treatment sessions to evaluate its safety and efficacy.

Group Type: EXPERIMENTAL

Vaginal Light Therapy - Twice

Intervention Type: DEVICE

Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in two treatment sessions.

Interventions

Vaginal light therapy - Once

Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in single treatment session.

Intervention Type: DEVICE

Vaginal Light Therapy - Once

Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in single treatment session.

Intervention Type: DEVICE

Vaginal Light Therapy - Twice

Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in two treatment sessions.

Intervention Type: DEVICE

Vaginal Light Therapy - Twice

Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in two treatment sessions.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: collaborator

UVISA Health ApS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Odense University Hospital

Odense C, , Denmark

Site Status: RECRUITING

Countries

Denmark

Facility Contacts

Department Doctor (Afdelingslæge)

Role: primary

Camilla.Viola.Palm@rsyd.dk

0045 31677080

Other Identifiers

Uvisa03.01

Identifier Type: -

Identifier Source: org_study_id