Clinical trial NCT06572488: Non-ablative Er:YAG for Recurrent Candidiasis
Official title: Exploring the Effects of Non-ablative Er:YAG Laser on Patients Suffering From Recurrent Vulvovaginal Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Espacio Gaspar Clinic
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 167
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Improvement of bothersome symptoms (burning sensation,/irritation, itching or soreness, dyspareunia, dysuria, abnormal vaginal discharge
timeFrame: Change from Baseline at 3 and 9 months after last intervention
Secondary outcomes:
measure: Change in lab cultures of vaginal swabs
timeFrame: Change from Baseline at 3 and 9 months after last intervention
measure: Recording of frequency and severity of adverse effects related to laser treatment
timeFrame: 9 months
measure: Patient satisfaction with 5-point Likert scale
timeFrame: Improvement from Baseline at 3 and 9 months after last intervention
Other outcomes:
Locations:
city: Mendoza
country: Argentina
facility: Uroclinica
Study officials:
affiliation: Espacio Gaspar Clinic
name: Adrian Gaspar, MD
role: PRINCIPAL_INVESTIGATOR
References: