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Completed

NCT Number: NCT06572488

Non-ablative Er:YAG for Recurrent 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.

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Key information

Conditions

Candidiasis, Vulvovaginal Bacterial Infections and Mycoses Candidiasis Candidiasis of Vagina Candidiasis, Genital Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infection, Candida Infections Mycoses Recurrent Candidiasis of Vagina Urogenital Diseases Vaginal Diseases Vaginal Yeast Infections Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Uroclinica

Mendoza, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult women (> 18 years)
  • diagnosis of recurrent vaginal yeast infection (> 4 infection per year)

Exclusion criteria

  • patients having contraindications to laser therapy (epilepsy, pregnancy, acute systemic infection)

Treatment and study plan

Non-ablative SMOOTH mode Er:YAG laser

Device

Four intravaginal treatments within four months.

Other names: SMOOTH mode, non-ablative Er:YAG laser

Primary outcomes

  1. 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"

Secondary outcomes

  1. Change in lab cultures of vaginal swabs

    Time frame: Change from Baseline at 3 and 9 months after last intervention

    Lab cultures of vaginal secretion on Sabouraud dextrose agar (SDA) were performed for diagnosis and determination of lead pathogen.

  2. Recording of frequency and severity of adverse effects related to laser treatment

    Time frame: 9 months

    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.

  3. Patient satisfaction with 5-point Likert scale

    Time frame: Improvement from Baseline at 3 and 9 months after last intervention

    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).

Sponsors and collaborators

Lead sponsor

Espacio Gaspar Clinic

Other

Registry information

Official study title

Exploring the Effects of Non-ablative Er:YAG Laser on Patients Suffering From Recurrent Vulvovaginal Candidiasis

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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