Light Treatment of Vaginal Infections in Reproductive Age Women

NCT06985433 | Completed DMC

• 1 other identifier: Uvisa03.01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis; Vulvovaginal Candidiases

Outcome Measures

Primary Outcomes (1)

• Patient reported reduction in symptoms of BV/VVC

  Patient-reported symptoms of BV and VVC will be recorded before and after the treatment through a vaginal health questionnaire to evaluate the efficacy of light treatment based on the following scale: Symptom severity: 0 - 4, Lower the score, better the outcome Impact on everyday life: 0 - 4, Lower the score, better the outcome

  Upto 2 months

Secondary Outcomes (3)

• Clinical resolution of BV and/or VVC

  Upto 2 months

• Healthier vaginal microbiome as compared to pre-treatment state.

  Upto 2 months

• Vaginal health questionnaire

  2 Weeks

Other Outcomes (1)

• No visual sign of tissue damage from light treatment.

  Upto 2 months

Study Arms (4)

Treatment of BV with single session of light treatment.

EXPERIMENTAL

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

Device: Vaginal light therapy - Once

Treatment of BV with two sessions of light treatment.

EXPERIMENTAL

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

Device: Vaginal Light Therapy - Twice

Treatment of VVC with single session of light treatment.

EXPERIMENTAL

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

Device: Vaginal Light Therapy - Once

Treatment of VVC with two sessions of light treatment.

EXPERIMENTAL

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

Device: Vaginal Light Therapy - Twice

Interventions

Vaginal Light Therapy - Once DEVICE

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

Treatment of BV with single session of light treatment.

Vaginal Light Therapy - Twice DEVICE

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

Treatment of BV with two sessions of light treatment.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UVISA Health ApS: lead
• Odense University Hospital: collaborator

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: June 5, 2025
• Primary Completion: December 29, 2025
• Study Completion: February 2, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Qualified researchers presenting a proposal for data use and approved scientific/clinical study plan can request access by contacting the Sponsor. Data sharing is subject to data use agreement to protect participant's confidentiality and the sponsor's proprietary interests.

Locations

DK (1)