Candidiasis, VulvovaginalNCT06572488
Non-ablative Er:YAG for Recurrent Candidiasis
A study testing Non-ablative SMOOTH mode Er:YAG laser in people with Candidiasis, Vulvovaginal and Candidiasis of Vagina, run by Espacio Gaspar Clinic at 1 site in Argentina.
Trial summary
The objective of the study wa to assess the safety, acceptability and effectiveness of non-ablative Er:YAG laser therapy for treatment of symptoms and microbiological conditions of women with recurrent vulvovaginal candidiasis (RVVC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Candidiasis, Vulvovaginal, Candidiasis of Vagina, Candidiasis, Genital
- What is being tested?
- Non-ablative SMOOTH mode Er:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteArgentina
- Study dates
- 3 Jan 2019to 26 Sep 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult women (> 18 years)
- diagnosis of recurrent vaginal yeast infection (> 4 infection per year)
Who cannot join
- patients having contraindications to laser therapy (epilepsy, pregnancy, acute systemic infection)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effects of Non-ablative Er:YAG Laser on Patients Suffering From Recurrent Vulvovaginal Candidiasis
The objective of the study wa to assess the safety, acceptability and effectiveness of non-ablative Er:YAG laser therapy for treatment of symptoms and microbiological conditions of women with recurrent vulvovaginal candidiasis (RVVC). Eligible patients have received 4 laser therapies within four moths and will be assessed at baseline, 3 months and 9 months after last laser therapy.
The effects of laser therapy have been assessed by following the vaginal microbial status, by assessing the five bothersome symptoms related to vaginal infection (burning, itching, dyspareunia, dysuria, and abnormal discharge), by assessing the overall patient satisfaction, and throughout the study the safety of the laser therapy has been monitored.
Read the detailed description
Genital candidiasis is a common fungal infection that affects both men and women, though it is more frequently observed in women. It is estimated that up to 75% of women will experience at least one episode of vulvovaginal candidiasis (VVC) during their lifetime. The primary causative agents are Candida albicans and other non-albicans pathogenic fungal species.
The likelihood of developing genital candidiasis can be influenced by factors such as age and hormonal changes. Women of reproductive age, especially those who are pregnant, using hormonal contraceptives, or experiencing hormonal fluctuations, are at higher risk. The highest prevalence rate, 9%, is reported among women aged 25 to 34 years. Antibiotic use, which can disrupt the body's microbial balance, is a known risk factor for genital candidiasis, along with other factors like obesity, uncontrolled diabetes, corticosteroid use, chronic stress, and certain lifestyle choices.
Clinical guidelines recommend oral fluconazole or itraconazole as the first-line treatment for recurrent vulvovaginal candidiasis (RVVC). However, after stopping maintenance therapy, a recurrence rate of 40%-50% is expected. While clinical resistance to antifungal agents is rare, overexposure to azoles can lead to resistant strains of C. albicans. Additionally, non-albicans Candida species, such as C. glabrata, often show dose-dependent susceptibility or resistance to fluconazole and other azole agents, and their prevalence is increasing. Given the limited therapeutic options, innovative treatment strategies are necessary.
- Conditions
- Candidiasis, Vulvovaginal, Candidiasis of Vagina, Candidiasis, Genital, Recurrent Candidiasis of Vagina, Infection, Candida, Vaginal Yeast Infections
- Being tested
- Non-ablative SMOOTH mode Er:YAG laser
- Keywords
- non-ablative, Er:YAG laser, Recurrent vaginal yeast infection, Recurrent vulvovaginal candidiasis, candidiasis, vaginal, genital
- Medical subject headings
- Candidiasis, Vulvovaginal, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-ablative SMOOTH mode Er:YAG laserDevice
Also called SMOOTH mode, non-ablative Er:YAG laser
Four intravaginal treatments within four months.
| Study group | Role | What they receive |
|---|---|---|
| Active therapy with non-ablative Er:YAG laser | Experimental | Patients underwent four laser sessions with non-ablative SMOOTH Er:YAG laser therapy, with 1 moth interval between sessions Receives: Device: Non-ablative SMOOTH mode Er:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of bothersome symptoms (burning sensation,/irritation, itching or soreness, dyspareunia, dysuria, abnormal vaginal discharge
Patients were required to assess the symptom severity on a 0-10 VAS (Visual Analog Pain) scale, 0 referring to "absence of symptom" and 10 referring to "intolerable symptom"
Measured: Change from Baseline at 3 and 9 months after last intervention
Secondary outcomes (3)
Change in lab cultures of vaginal swabs
Lab cultures of vaginal secretion on Sabouraud dextrose agar (SDA) were performed for diagnosis and determination of lead pathogen.
Measured: Change from Baseline at 3 and 9 months after last intervention
Recording of frequency and severity of adverse effects related to laser treatment
Each visit included recording of any adverse effect. Patients were instructed to report and adverse effect that may have occured during the whole duration of the study.
Measured: 9 months
Patient satisfaction with 5-point Likert scale
Patients were asked to assess their global satisfaction with the treatment on a 5-point Likert scale (1-Very unsatisfied, 2-Unsatisfied, 3-Neutral, 4-Satisfied, 5-Very satisfied).
Measured: Improvement from Baseline at 3 and 9 months after last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start3 Jan 2019
- Primary completion26 Sep 2022
- Study completion26 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, VulvovaginalStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Espacio Gaspar Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Gaspar, Espacio Gaspar Clinic
- Investigators
- Adrian Gaspar, MD, Principal investigator, Espacio Gaspar Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572488
- Sponsor's protocol ID
- CAND/01
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Non-ablative Er:YAG Laser on Patients Suffering From Recurrent Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT06572488
- Acronym / sponsor ID
- CAND/01
- Conditions
- Candidiasis, Vulvovaginal, Candidiasis of Vagina, Candidiasis, Genital, Recurrent Candidiasis of Vagina, Infection, Candida, Vaginal Yeast Infections
- Keywords
- non-ablative, Er:YAG laser, Recurrent vaginal yeast infection, Recurrent vulvovaginal candidiasis, candidiasis, vaginal, genital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Espacio Gaspar ClinicUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 27 Aug 2024 (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.
The objective of the study wa to assess the safety, acceptability and effectiveness of non-ablative Er:YAG laser therapy for treatment of symptoms and microbiological conditions of women with recurrent vulvovaginal candidiasis (RVVC). Eligible patients have received 4 laser therapies within four moths and will be assessed at baseline, 3 months and 9 months after last laser therapy.
The effects of laser therapy have been assessed by following the vaginal microbial status, by assessing the five bothersome symptoms related to vaginal infection (burning, itching, dyspareunia, dysuria, and abnormal discharge), by assessing the overall patient satisfaction, and throughout the study the safety of the laser therapy has been monitored.
Detailed description
Genital candidiasis is a common fungal infection that affects both men and women, though it is more frequently observed in women. It is estimated that up to 75% of women will experience at least one episode of vulvovaginal candidiasis (VVC) during their lifetime. The primary causative agents are Candida albicans and other non-albicans pathogenic fungal species.
The likelihood of developing genital candidiasis can be influenced by factors such as age and hormonal changes. Women of reproductive age, especially those who are pregnant, using hormonal contraceptives, or experiencing hormonal fluctuations, are at higher risk. The highest prevalence rate, 9%, is reported among women aged 25 to 34 years. Antibiotic use, which can disrupt the body's microbial balance, is a known risk factor for genital candidiasis, along with other factors like obesity, uncontrolled diabetes, corticosteroid use, chronic stress, and certain lifestyle choices.
Clinical guidelines recommend oral fluconazole or itraconazole as the first-line treatment for recurrent vulvovaginal candidiasis (RVVC). However, after stopping maintenance therapy, a recurrence rate of 40%-50% is expected. While clinical resistance to antifungal agents is rare, overexposure to azoles can lead to resistant strains of C. albicans. Additionally, non-albicans Candida species, such as C. glabrata, often show dose-dependent susceptibility or resistance to fluconazole and other azole agents, and their prevalence is increasing. Given the limited therapeutic options, innovative treatment strategies are necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active therapy with non-ablative Er:YAG laser | Experimental | Device: Non-ablative SMOOTH mode Er:YAG laserPatients underwent four laser sessions with non-ablative SMOOTH Er:YAG laser therapy, with 1 moth interval between sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult women (> 18 years)
- diagnosis of recurrent vaginal yeast infection (> 4 infection per year)
Key exclusion criteria (1 listed)
- patients having contraindications to laser therapy (epilepsy, pregnancy, acute systemic infection)
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 |
|---|---|---|
| Non-ablative SMOOTH mode Er:YAG laserAlso: SMOOTH mode, non-ablative Er:YAG laserFour intravaginal treatments within four months. | Device | Active therapy with non-ablative Er:YAG laser |
Primary outcome
Improvement of bothersome symptoms (burning sensation,/irritation, itching or soreness, dyspareunia, dysuria, abnormal vaginal discharge
Time frame: Change from Baseline at 3 and 9 months after last intervention
Patients were required to assess the symptom severity on a 0-10 VAS (Visual Analog Pain) scale, 0 referring to "absence of symptom" and 10 referring to "intolerable symptom"
3 secondary outcomes
Change in lab cultures of vaginal swabs
Time frame: Change from Baseline at 3 and 9 months after last intervention
Recording of frequency and severity of adverse effects related to laser treatment
Time frame: 9 months
Patient satisfaction with 5-point Likert scale
Time frame: Improvement from Baseline at 3 and 9 months after last intervention
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 27 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Adrian Gaspar, MD principal investigator
Espacio Gaspar Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-ablative SMOOTH mode Er:YAG laser in people with Candidiasis, Vulvovaginal and Candidiasis of Vagina, run by Espacio Gaspar Clinic at 1 site in Argentina.
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 2 inclusion and 1 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 27 Aug 2024. 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 Argentina. 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?
Improvement of bothersome symptoms (burning sensation,/irritation, itching or soreness, dyspareunia, dysuria, abnormal vaginal discharge (time frame: Change from Baseline at 3 and 9 months after last intervention). 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 27 Aug 2024.