Vulvar Lichen Sclerosus: Expression of Inflammatory Markers in a Randomized Clinical Trial With Clobetasol Versus Laser
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation and comparison of inflammatory biomarkers before and after treatment with clobetasol or CO2 laser.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women older than 21 years; histological diagnostic of vulvar lichen sclerosus and no previous treatment with topic corticoesteroid
排除标准
- •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
研究组 & 干预措施
Paricipants randomized for Clobetasol ointment group
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
干预措施: Fractional microablative CO2 Laser (Device)
Participants randomized for Fractional Carbon dioxide (CO2 ) laser group treatment
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.
干预措施: Fractional microablative CO2 Laser (Device)
结局指标
主要结局
Evaluation and comparison of inflammatory biomarkers before and after treatment with clobetasol or CO2 laser.
时间窗: Each participant will be monitored from registration, throughout treatment, and up to three months after the end of treatment.
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.
To evaluate the performance of CO2 laser in vulvar lichen sclerosus in relation to inflammatory skin markers and compare to clobetasol
时间窗: From enrollment to a second biopsy 3 months after treatment
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.
Evaluation and comparison of inflammatory biomarkers before and after treatment with clobetasol or CO2 laser.
时间窗: Each participant will be monitored from registration, throughout treatment, and up to three months after the end of treatment.
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.
To evaluate the performance of CO2 laser in vulvar lichen sclerosus in relation to inflammatory skin markers and compare to clobetasol
时间窗: From enrollment to a second biopsy 3 months after treatment
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.
次要结局
未报告次要终点
研究者
Andréa Cytryn
Principal investigator
Universidade Federal do Rio de Janeiro