An interventional study of Non-ablative SMOOTH mode Er:YAG laser in Candidiasis, Vulvovaginal, Candidiasis of Vagina and Candidiasis, Genital, sponsored by Espacio Gaspar Clinic. Completed at 1 site in Argentina. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Espacio Gaspar Clinic · Not applicable, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.
This study's enrollment of 167 is above the median of 126 across 91 interventional studies indexed under Candidiasis, Vulvovaginal.
Browse Candidiasis, Vulvovaginal studies →Espacio Gaspar Clinic is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients underwent four laser sessions with non-ablative SMOOTH Er:YAG laser therapy, with 1 moth interval between sessions
Device: Non-ablative SMOOTH mode Er:YAG laser
Four intravaginal treatments within four months.
Also known as: SMOOTH mode, non-ablative Er:YAG laser
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"
Time frame: Change from Baseline at 3 and 9 months after last intervention
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.
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
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.
Time frame: 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).
Time frame: Improvement from Baseline at 3 and 9 months after last intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Sep 2022, 44 months.
Of 20 interventional studies with no phase under Candidiasis, Vulvovaginal, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's 44 months is above that.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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