Vulvovaginal Candidiasis
Conditions
Interventions
A randomized clinical trial with single blinding will be conducted, in which participants will be unaware of their allocation to the intervention groups. The sample will consist of 60 women of reprodu
Sponsors
Maternidade Escola Januário Cicco
Empresa LOKTAL
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women over 18 years of age in reproductive age; heterosexual; sexually active; presenting clinical signs compatible with vulvovaginal candidiasis; with laboratory-confirmed diagnosis of recurrent vulvovaginal candidiasis characterized by the occurrence of more than three episodes of infection within a 12-month period
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women; women with known hypersensitivity or allergy to methylene blue; presence of anatomical vaginal malformations; inability to understand or sign the Informed Consent Form; current or past diagnosis of genital neoplasia; history of photosensitivity or use of photosensitizing medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe a significant reduction in the clinical signs and symptoms associated with recurrent vulvovaginal candidiasis, including itching, burning, discharge, and dyspareunia, assessed using the standardized clinical score for vulvovaginal candidiasis and by the presence or absence of hyphae and spores in vaginal smears stained by the Gram method, collected before and after the intervention with photodynamic therapy using red light-emitting diode | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe an increase in the proportion of lactobacilli in the vaginal microbiota, assessed by percentage quantification in vaginal smears obtained before and after treatment; improvement in quality of life and sexual function, measured by validated questionnaires applied in the pre- and post-intervention periods; reduction in infection recurrence rate during the six-month follow-up period after treatment; evaluation of the safety and tolerability of photodynamic therapy using red light-emitting diode, considering the absence of local or systemic adverse events reported by participants during and after treatment | — |
Countries
Brazil
Contacts
Public ContactAna Katherine Gonçalves
CCS/UFRN - Centro De Ciências da Saúde
Outcome results
None listed