Non-ablative Er:YAG for Recurrent Candidiasis
NCT06572488 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167
Last updated 2024-08-27
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.
Conditions
- Candidiasis, Vulvovaginal
- Candidiasis of Vagina
- Candidiasis, Genital
- Recurrent Candidiasis of Vagina
- Infection, Candida
- Vaginal Yeast Infections
Interventions
- DEVICE
-
Non-ablative SMOOTH mode Er:YAG laser
Four intravaginal treatments within four months.
Sponsors & Collaborators
-
Espacio Gaspar Clinic
lead OTHER
Principal Investigators
-
Adrian Gaspar, MD · Espacio Gaspar Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-03
- Primary Completion
- 2022-09-26
- Completion
- 2022-09-26
Countries
- Argentina
Study Locations
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