Bacterial VaginosisNCT06985433
Light Treatment of Vaginal Infections in Reproductive Age Women
A study testing Vaginal light therapy - Once and Vaginal Light Therapy - Twice in people with Bacterial Vaginosis and Vulvovaginal Candidiases, run by UVISA Health ApS at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bacterial Vaginosis, Vulvovaginal Candidiases
- What is being tested?
- Vaginal light therapy - Once and Vaginal Light Therapy - Twice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jun 2025to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years of age
- Normal gynecological status
- Diagnosed for BV or VVC
- Not pregnant
- No signs of other genital tract infections
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Light Treatment of Symptomatic Vulvovaginitis
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.
Read the 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
- Being tested
- Vaginal light therapy - Once, Vaginal Light Therapy - Twice
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal light therapy - OnceDevice
Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in single treatment session.
Vaginal Light Therapy - OnceDevice
Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in single treatment session.
Vaginal Light Therapy - TwiceDevice
Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in two treatment sessions.
Vaginal Light Therapy - TwiceDevice
Vaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in two treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Vaginal Light Therapy - Twice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Upto 2 months
Secondary outcomes (3)
Clinical resolution of BV and/or VVC
Patients will be examined for the objective signs of BV and VVC post treatment.
Measured: Upto 2 months
Healthier vaginal microbiome as compared to pre-treatment state.
Vaginal swabs will be collected to evaluate vaginal microbiome dynamics before and after the treatment.
Measured: Upto 2 months
Vaginal health questionnaire
User experience of the device will be evaluated using the vaginal health questionnaire and following scale:
Device Use Experience: 0 - 4, Lower the score, better the outcome
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start5 Jun 2025
- Primary completion29 Dec 2025
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- UVISA Health ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985433
- Sponsor's protocol ID
- Uvisa03.01
- Status last verified
- Feb 2026
- First submitted
- 14 May 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data related to primary and secondary outcomes, which are aggregated in tabular or graphical form.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Treatment of Symptomatic Vulvovaginitis
- ClinicalTrials.gov ID
- NCT06985433
- Acronym / sponsor ID
- Uvisa03.01
- Conditions
- Bacterial Vaginosis, Vulvovaginal Candidiases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- UVISA Health ApSIndustry (pharma, biotech, devices)
- Collaborators
- Odense University Hospital
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment of BV with single session of light treatment. | Experimental | Device: Vaginal light therapy - OnceA group of 10 patients will receive light therapy in single treatment session to evaluate its safety and efficacy. |
| Treatment of BV with two sessions of light treatment. | Experimental | Device: Vaginal Light Therapy - TwiceA group of 10 patients will receive light therapy in two treatment sessions to evaluate its safety and efficacy. |
| Treatment of VVC with single session of light treatment. | Experimental | Device: Vaginal Light Therapy - OnceA group of 10 patients will receive light therapy in single treatment session to evaluate its safety and efficacy. |
| Treatment of VVC with two sessions of light treatment. | Experimental | Device: Vaginal Light Therapy - TwiceA group of 10 patients will receive light therapy in two treatment sessions to evaluate its safety and efficacy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-45 years of age
- Normal gynecological status
- Diagnosed for BV or VVC
- Not pregnant
- No signs of other genital tract infections
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal light therapy - OnceVaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in single treatment session. | Device | Treatment of BV with single session of light treatment. |
| Vaginal Light Therapy - OnceVaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in single treatment session. | Device | Treatment of VVC with single session of light treatment. |
| Vaginal Light Therapy - TwiceVaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in two treatment sessions. | Device | Treatment of BV with two sessions of light treatment. |
| Vaginal Light Therapy - TwiceVaginal light therapy device will deliver UVA and blue light to target symptom causing microbes in two treatment sessions. | Device | Treatment of VVC with two sessions of light treatment. |
Primary outcome
Patient reported reduction in symptoms of BV/VVC
Time frame: Upto 2 months
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
3 secondary outcomes
Clinical resolution of BV and/or VVC
Time frame: Upto 2 months
Healthier vaginal microbiome as compared to pre-treatment state.
Time frame: Upto 2 months
Vaginal health questionnaire
Time frame: 2 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified data related to primary and secondary outcomes, which are aggregated in tabular or graphical form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal light therapy - Once and Vaginal Light Therapy - Twice in people with Bacterial Vaginosis and Vulvovaginal Candidiases, run by UVISA Health ApS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported reduction in symptoms of BV/VVC (time frame: Upto 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.