Candidiasis of vulva and vagina
Conditions
Interventions
Randomized clinical trial, single-blind, in accordance with the CONSORT guideline. Blue intravaginal light-emitting diode (LED) phototherapy will be applied to female patients with a history of recurr
Sponsors
Hospital de Clínicas de Porto Alegre
Hospital de Clínicas de Porto Alegre
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women of childbearing age and over 18 years old, with a history of RVC and previous unsuccessful conventional treatment, after signing an Informed Consent Form (ICF). Diagnostic confirmation will be required with specific culture for Candida or by fresh examination of vaginal secretion, associated with signs and symptoms suggestive of RVC, with a semiquantitative score of more than 4 points.
Exclusion criteria
Exclusion criteria: Pregnancy, diabetes mellitus, human immunodeficiency virus (HIV) infection, epilepsy, glaucoma, tuberculosis, under chemotherapy treatment, use of broad spectrum antibiotics (Tetracycline, Ampicillin, Cephalosporin), prolonged use of glucocorticoid (time equal to or greater than 3 weeks), change of contraceptive method during the study period, use of topical or oral azoles (in addition to the drugs provided) during the recruitment period, patients with a pacemaker or hip prosthesis, current and/or treated genital neoplasia, history of photosensitivity, use of photosensitive drugs, application to a bleeding area, hypersensitivity to Fluconazole or azole compounds, withdrawal of consent or loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy and applicability of treatment with intravaginal blue LED phototherapy, according to the time of light emission, in cases of RVC. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the frequency of recurrence of Candida species at the end of treatment. ;To evaluate symptomatological recurrence at the end of treatment. ;To evaluate the adverse effects of intravaginal blue LED phototherapy. ;To evaluate the adverse effects of Fluconazole use in induction and maintenance regimens. ;To evaluate the degree of overall satisfaction of the patients with the proposed treatment through a score given by the patient. | — |
Countries
Brazil
Contacts
Public ContactJanete;Isadora Vettorazzi;Bastiani Biondo
Hospital de Clínicas de Porto Alegre;Hospital de Clínicas de Porto Alegre
Outcome results
None listed