Non-ablative Er:YAG for Recurrent Candidiasis

Espacio Gaspar Clinic

Status: Completed

Conditions: Vaginal Yeast Infections; Recurrent Candidiasis of Vagina; Candidiasis, Genital; Candidiasis of Vagina; Infection, Candida; Candidiasis, Vulvovaginal

Treatments: Device: Non-ablative SMOOTH mode Er:YAG laser

Study type: Interventional

Funder types: Other

Identifiers

NCT06572488

CAND/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 167 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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167 participants in 1 patient group

Active therapy with non-ablative Er:YAG laser

Experimental group

Description:

Patients underwent four laser sessions with non-ablative SMOOTH Er:YAG laser therapy, with 1 moth interval between sessions

Treatment:

Device: Non-ablative SMOOTH mode Er:YAG laser