Light Treatment of Vaginal Infections in Reproductive Age Women

UVISA Health ApS

Status: Enrolling

Conditions: Bacterial Vaginosis; Vulvovaginal Candidiases

Treatments: Device: Vaginal Light Therapy - Twice; Device: Vaginal light therapy - Once; Device: Vaginal Light Therapy - Once

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06985433

Uvisa03.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Treatment of BV with single session of light treatment.

Experimental group

Description:

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

Treatment:

Device: Vaginal light therapy - Once

Treatment of BV with two sessions of light treatment.

Experimental group

Description:

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

Treatment:

Device: Vaginal Light Therapy - Twice

Device: Vaginal Light Therapy - Twice

Treatment of VVC with single session of light treatment.

Experimental group

Description:

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

Treatment:

Device: Vaginal Light Therapy - Once

Treatment of VVC with two sessions of light treatment.

Experimental group

Description:

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

Treatment:

Device: Vaginal Light Therapy - Twice

Device: Vaginal Light Therapy - Twice