An interventional study of Fractional microablative CO2 Laser in Vulvar Lichen Sclerosus, sponsored by Universidade Federal do Rio de Janeiro. Recruiting at 1 site in Brazil. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Universidade Federal do Rio de Janeiro · Not applicable, Interventional, and Treatment
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 aspects, such as improvement in itching, dyspareunia and appearance of the vulva, along with satisfaction with the treatment, using the Visual Analogue Scale (VAS) from 1 to 10.
With this study, the investigators want to know if fractional CO2 laser can reduce the inflammatory process and symptoms in vulvar lichen sclerosus such as itching, and if this could be an alternative treatment for this condition.
33 studies on the registry are indexed under Vulvar Lichen Sclerosus; 10 are open to participants now.
This study's planned enrollment of 40 is close to the median of 39 across 30 interventional studies indexed under Vulvar Lichen Sclerosus.
Browse Vulvar Lichen Sclerosus studies →Universidade Federal do Rio de Janeiro is the lead sponsor of 123 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Women older than 21 years; histological diagnostic of vulvar lichen sclerosus and no previous treatment with topic corticoesteroid
Exclusion Criteria: Women that don't agree in taking part of the study; other concomitant vulvar diseases; pre malignant vulvar disease HPV dependent and independent; previous pelvic radiotherapy
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Participants in this group will apply clobetasol propionate 0.05% ointment to the vulvar affected area in an amount sufficient to cover the finger tip according to standard treatment protocol: every day in the first month every other day in the second month twice a week (for example: Mondays and Thursdays) in the third month
Device: Fractional microablative CO2 Laser
Fractional microablative CO2 laser An anesthetic ointment provided by the principal investigator, applied on vulva skin, perineal area and vulvar vestibule 30 - 45 minutes before the Session of CO2 laser. Three sessions spaced four weeks apart, with instructions after each session, such as avoiding sexual intercourse for five days and using a product like petroleum jelly for relief for a few days.
Device: Fractional microablative CO2 Laser
In this study the investigators use the laser device without any topic esteroid previous or during the period of laser sessions
Evaluation and comparison of inflammatory biomarkers before and after treatment with clobetasol or CO2 laser.
Before and after each of the two treatments, a vulvar punch biopsy will be performed. The fragment will then be analyzed using immunohistochemistry to assess changes in inflammatory biomarkers.
Time frame: Each participant will be monitored from registration, throughout treatment, and up to three months after the end of treatment.
To evaluate the performance of CO2 laser in vulvar lichen sclerosus in relation to inflammatory skin markers and compare to clobetasol
In vulvar skin fragment obtained by punch biopsy, some inflammatory biomarkers such as TGF-β, INF-γ, VEGF, and IL-10 will be evaluated before and three months after the last laser session. The biomarkers will be quantified by immunohistochemistry at the Immunology and Immunogenetics Laboratory of Fiocruz. For the count, a compound optical microscope will be used, consisting of a 40x objective lens and a 10x grating eyepiece. The total number of cells positive for the marker being analyzed will be recorded in each field.
Time frame: From enrollment to a second biopsy 3 months after treatment
Plan to share: Yes — Sociodemographic data such as age, race, marital status, education. Clnical data such as parity, mode of delivery, active or inactive sexual life, period of reproductive life and current contraception, presence of autoimmune diseases, comorbidities such as hypertension, diabetes, regular medications and smoking
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data becomes available 6 months after publication.
Ran from Jun 2022 to primary completion in Sep 2025, 38 months.
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