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Lichen Sclerosus clinical trials

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NCT ID: NCT06135402 Recruiting - Lichen Sclerosus Clinical Trials

Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus

Start date: November 10, 2023
Phase: N/A
Study type: Interventional

With this trial the investigators look for the effect of Laser maintenance therapy in patients with vulvar lichen sclerosus compared to the maintenance standard treatment clobetasol propionate.

NCT ID: NCT05671263 Recruiting - Lichen Sclerosus Clinical Trials

Genital Lichen Sclerosus - Epidemiology, Comorbidities and the Role of Vulvar and Penile Microbiome

Start date: January 14, 2022
Phase:
Study type: Observational

In genital LSc, three pathological processes are implicated in disease development: inflammation, sclerosis/fibrosis and neoplasia. The role of genital microbiome is still to be investigated and explained. Genital LSc microbiome studies are missing. The ecological community of microorganisms that are present on our body and of the body itself defines the human skin microbiome. Revealing the genital microbiome may potentially lead to new therapies of genital LSc. The primary aim is to analyze genital microbiome before and after the treatment (topical corticosteroids or topical calcineurin inhibitors or circumcision) in both male and female patients diagnosed with genital LSc as well as to analyze genital microbiome in healthy (non-genital LSc) controls. 2) The secondary aim is to determine incidence and prevalence of male and female genital LSc in Sweden and its association with other diseases. The Study will be divided in two parts 1. PART A: Prospective case control study on the effect of treatment on the genital skin microbiome of patients with genital LSc and on the role of genital microbiome in treatment resistance of genital LSc 2. PART B: Swedish nationwide register-based cohort study to analyse incidence, prevalence and comorbidities of genital LSc

NCT ID: NCT05010421 Recruiting - Lichen Sclerosus Clinical Trials

Laser vs Clobetasol for Lichen Sclerosus

Start date: November 2, 2021
Phase: Phase 3
Study type: Interventional

Lichen sclerosus (LS) is a common autoimmune disease of the genital skin. It affects 1/900 women with an age peak in the sixth decade of life and is manifested by chronic inflammation of the genital, perineal, and perianal areas associated with itching, burning, pain, and soreness. In addition, LS is associated with an increased risk of vulvar cancer. Treatment options for LS include topical steroids such as clobetasol, immunomodulators such as tacrolimus, and non-ablative laser treatment. Although both treatments are well documented and used in clinical practice, direct comparative studies of the efficacy of topical corticosteroids versus laser treatment in women with LS are rare. For example, a PubMed literature search (search date 2021-03-14; search terms: lichen sclerosus, laser, corticosteroids, steroids, clobetasol, randomized) identified only a single randomized trial with limited power. Given the available evidence, further high-quality studies are needed to define the superiority/inferiority of the different available treatment options such as nonablative lasers and topical corticosteroids. Therefore, in this prospective, randomized, open-label, comparative study, treatment success after 3 courses of non-ablative treatment with CO2 laser every 14 days will be compared with treatment success after topical application of clobetasol 0.05% over 3 months (daily in the first month, every other day in month 2, and 3 times/week during month 3) at the time point 3 months after treatment initiation.

NCT ID: NCT03561428 Recruiting - Lichen Sclerosus Clinical Trials

Biomarkers of Lichen Sclerosus

Start date: November 27, 2017
Phase:
Study type: Observational

Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant lack of sexual pleasure or pain. Lastly, 4-6% of women with LS will develop vulvar cancer. The purpose of this study is to learn the gene expression file changes in skins affected by LS as compared to normal skins in order to discover the mechanism of the LS, and further to develop effective drugs to treat the condition.