Non-ablative Er:YAG for Recurrent Candidiasis

NCT ID: NCT06572488

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2022-09-26

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active therapy with non-ablative Er:YAG laser

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

Group Type: EXPERIMENTAL

Non-ablative SMOOTH mode Er:YAG laser

Intervention Type: DEVICE

Four intravaginal treatments within four months.

Interventions

Non-ablative SMOOTH mode Er:YAG laser

Four intravaginal treatments within four months.

Intervention Type: DEVICE

Other Intervention Names

SMOOTH mode; non-ablative Er:YAG laser

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Espacio Gaspar Clinic

OTHER

Sponsor Role: lead

Responsible Party

Adrian Gaspar

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adrian Gaspar, MD

Role: PRINCIPAL_INVESTIGATOR

Espacio Gaspar Clinic

Locations

Uroclinica

Mendoza, , Argentina

Countries

Argentina

Other Identifiers

CAND/01

Identifier Type: -

Identifier Source: org_study_id