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Vulvar Lichen Sclerosus clinical trials

View clinical trials related to Vulvar Lichen Sclerosus.

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NCT ID: NCT06360705 Recruiting - Clinical trials for Vulvar Lichen Sclerosus

StrataMGT for the Treatment of Vulvar Lichen Sclerosus

Start date: April 2024
Phase: N/A
Study type: Interventional

This study is designed to evaluate the efficacy and safety of StrataMGT for the treatment of vulvar lichen sclerosus.

NCT ID: NCT06132919 Recruiting - Clinical trials for Vulvar Lichen Sclerosus

Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS)

Orchid 1
Start date: October 11, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to explore the efficacy and safety of MC2-25 cream and MC2-25 vehicle in women with vulvar lichen schelosus (VLS).

NCT ID: NCT05953090 Recruiting - Vaginal Atrophy Clinical Trials

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

VALOR
Start date: October 30, 2023
Phase: N/A
Study type: Interventional

Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.

NCT ID: NCT05364515 Not yet recruiting - Clinical trials for Lichen Sclerosus of Vulva

Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva

PRGF
Start date: October 2022
Phase: Phase 3
Study type: Interventional

Lichen sclerosus is a chronic dermatosis of the skin and semimucous membranes, characterized by the presence of well-defined atrophic white papules or plaques, which appear mainly on the skin of the anogenital region of both sexes, and less frequently on the skin of the trunk. , mainly affecting postmenopausal women. There is no absolutely effective treatment. Only potent topical corticosteroids control symptoms and improve outcomes, although prolonged use can increase skin atrophy. In severe vulvar lesions, 0.05% clobetasol propionate is indicated, followed by a less potent topical corticosteroid. Relapses often occur if treatment is discontinued altogether, but respond well to reintroduction of treatment. Plasma Rich in Growth Factors (PRGF®) is a mixture of autologous proteins, prepared from a certain volume of platelet-rich plasma obtained from a small volume of blood, which does not contain leukocytes. To date, there have been no studies evaluating PRGF® treatment in vulvar lichen sclerosus. However, there are several publications that assess the efficacy of PRPs as a treatment for vulvar lichen sclerosus. This clinical study has been designed with the aim of evaluating the efficacy of PRGF® in reducing the main symptoms of vaginal lichen sclerosus atrophicus.

NCT ID: NCT05251220 Completed - Clinical trials for Genitourinary Syndrome of Menopause

Efficacy and Safety of the Neodymium Laser in Treatment of Urogenital Tract Diseases in Women

Start date: January 1, 2018
Phase:
Study type: Observational

Study objective: To evaluate the efficacy and safety of the Magic Max neodymium laser in the medical treatment of women with symptoms of genitourinary syndrome of menopausal, vulvar lichen sclerosus and pelvic floor muscle reduction.

NCT ID: NCT05250466 Recruiting - Clinical trials for Vulvar Lichen Sclerosus

A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia

Start date: July 7, 2022
Phase: N/A
Study type: Interventional

The study was designed as a prospective, multicenter, randomized, open-label, parallel-controlled clinical trial. The study population was patients with vulvar leukoplakia, and compared the efficacy and safety of AI temperature-controlled radio frequency technology and electrical stimulation in the treatment of vulvar leukoplakia. According to the research purpose, the sample size was calculated and determined to be 120 cases, and they were randomly assigned to the observation group and the control group according to the ratio of 1:1, namely 60 cases in the radio frequency observation group and 60 cases in the electric stimulation control group.

NCT ID: NCT05243563 Recruiting - Clinical trials for Vulvar Lichen Sclerosus

Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?

Start date: April 13, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.

NCT ID: NCT05228483 Recruiting - Clinical trials for Vulva Lichen Sclerosus

Carbon Dioxide(CO2)Fractional Laser Plus Photodynamic Therapy in Female Patients With Vulvar Lichen Sclerosus

Start date: November 23, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of CO2 fractional laser combined with photodynamic therapy in female patients with vulvar lichen sclerosus.

NCT ID: NCT05147129 Completed - Clinical trials for Vulvar Lichen Sclerosus

Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus

Start date: September 16, 2021
Phase:
Study type: Observational

Vulvar lichen sclerosus (LS) is a chronic inflammatory disease, often diagnosed at late stages after scarring has obliterated normal vulvar architecture and severely affected a woman's quality of life. First line therapy for vulvar LS is ultrapotent topical steroids. If left untreated, this condition can cause complete stenosis of the vaginal introitus and 5% of patients may develop squamous cell carcinoma (SCC). Lichen sclerosus is more common in pre-pubertal children and in post-menopausal women suggesting that hormonal shifts may contribute to disease pathogenesis. Small studies in children with LS have also shown that the microbiome is altered in LS. Little is known about the skin microbiota in postmenopausal patients with vulvar LS. To determine if the microbiome is altered in vulvar skin of postmenopausal patients with LS, this study will use 16s sequencing to broadly characterize the microbiota of vulvar skin with LS compared to control vulvar skin. The study team hypothesizes that patients with vulvar LS will have a unique vulvar microbial signature compared to age-matched controls. This study also seeks to elucidate differences in the vulvar microbiome of patients with LS after treatment of their underlying condition. The study team hypothesizes that the vulvar microbiome will change after treatment for vulvar LS. Vulvar dermatoses are an understudied area in dermatology with limited therapeutic options. Innumerable women often suffer in silence with vulvar LS. The long-term goal of this work is to understand factors that contribute to vulvar LS so that intervention may be undertaken before irreversible scarring and SCC develop.

NCT ID: NCT05060224 Completed - Quality of Life Clinical Trials

Low-Level Laser Therapy: an Efficient Supplement to Treatments of Vulvar Lichen Sclerosus to Improve Quality of Life

Start date: January 2016
Phase: N/A
Study type: Interventional

Objectives: The aim of this study was to investigate whether Low Level Laser therapy (LLLT) can improve the quality of life in women with Lichen Sclerosus (LS) and insufficient topical treatment. Methods: In a clinical trial study conducted between January 2016 and July 2018, the investigators included 100 women with LS with insufficient topical treatment. All participants received ten LLLT treatments (808 nm and 500 mW) over a period of 8 weeks. The first four treatments where planned as two treatments per week. The remaining six treatments where planned as once a week. The effect was monitored by a Danish health-related quality of life tool (HRQoL test).