Randomized clinical trial with fractional CO2 laser and Clobetasol in the treatment of Vulvar Lichen Sclerosus: a clinic study of feasibility

Abstract

Abstract Objectives The main objective of the study was to describe and compare the feasibility of using fractional CO2 laser to the usual treatment with Clobetasol. Randomized clinical trials brought together 20 women from a Brazilian university hospital, 9 of them were submitted to Clobetasol treatment and 11 to laser therapy. Sociodemographic data were obtained and quality of life parameters, vulvar anatomy, self-perception and histopathological analysis of vulvar biopsies were evaluated. Evaluations were made before the beginning of the treatment, during its implementation, right after its completion (3 months), and 12 months after. The SPSS 14.0 software was used, obtaining descriptive measurements. The level of significance adopted was 5%. Results The clinical/anatomical characteristics of the vulva did not differ between the treatment groups, as much before as after its performance. There was no statistically significant difference between the treatments performed regarding the impact on the life quality of the patients. A higher satisfaction degree with the treatment was obtained with the patients in the Laser group in the third month of evaluation. Laser therapy also revealed higher occurrence of telangiectasia after treatment completion. Fractional CO2 laser has proven to be well accepted and is a promising therapeutic option. Registration number and name of trial registry The institutional review board status was approved by the Research Ethics Committee of HU/ UFJF under advisory number 2881073 and registered in the Brazilian Clinical Trials, with consent under registration RBR-4p9s5y. Access link: https://ensaiosclinicos.gov.br/rg/RBR-4p9s5y