Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572488
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Non-ablative ErYAG for Recurrent Candidiasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploring the Effects of Non-ablative ErYAG Laser on Patients Suffering From Recurrent Vulvovaginal Candidiasis
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study wa to assess the safety acceptability and effectiveness of non-ablative ErYAG 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
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 bodys 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
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 bodys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None