Condition: Vulvar Lichen Sclerosus · Sponsor: Universidade Federal do Rio de Janeiro
The present study is a Clinical trial that compares clobetasol ointment versus Fractional CO2 laser for vulvar lichen sclerosus (VLE) treatment confirmed by histology, with no previous treatment. Lichen sclerosus is a chronic inflamatory disease that affects the vulvar skin in the majority of cases, generally in peri and post menopause. The main symptom is pruritus, along with dispareunia and vulvar pain. If not treated, it can leads to vulvar anatomy distortion and altough small, there is risk of neoplastic transformation towards pre cancer and invasive vulvar cancer. Clobetasol ointment is the standard treatment, but prolonged use can cause some adverse effects, such as thinning the skin, fungal infections, and exacerbation of symptoms. Forty participants are being randomized to clobetasol group, three months with reducing frequency and the other group of participants, to fractional dioxid carbon (CO2) laser for three sessions four weeks apart. At the beggining and three months after the completion of each treatment, a punch biopsy will be taken for every participant. The principal aim is to compare some inflamatory biomarkers before and after each treatment and compare them by imunohistoquemestry at Imunology and Imunogenetic Laboratory in Fiocruz, Rio de janeiro, Brazil. Secondary outcomes include clinical response and changes in vulvar anatomy, assessed using the Sheinis \& Selk questionnaire before and after each treatment, as well as the evaluation of some clinical as…
This description comes directly from the study's public registry record.
Andréa Cytryn, Master Degree · +55 21 98123 0332 · andreacytryn@hotmail.com
Yara Lúcia M. Furtado de Melo, PhD in Surgical Sciences · + 55 21 999826257 · yarafurtadorj@gmail.com
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| Institute of Gynecology of the Federal University of Rio de Janeiro | Rio de Janeiro, Rio de Janeiro, Brazil | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07240519