Biomarkers of Lichen Sclerosus

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Lichen sclerosus (LS) is a chronic, lymphocyte mediated cutaneous disorder affecting approximately one in seventy women. Presenting symptoms may include intense pruritis, pain, burning, and dyspareunia. This disorder may affect any area of the skin, but has a notable predilection for the female genital region, in particular, the vulva, per anal area and the groin. Affected females outnumber affected males by 13:1. Typically, the patient is a menopausal woman, but prepubertal girls and women of all ages may be affected. The typical lesions of lichen sclerosus are white plaques and papules, often with areas of ecchymosis, excoriation, and ulceration. Often, there is destruction of the vulvar architecture with scarring of the clitoral prepuce, resorption of the labia minora, and narrowing of the introitus. Vulvar lichen sclerosus has a 4%-6% transformation malignant rate and women with the disease are at a 250-fold increased risk for developing vulvar carcinoma than women without lichen sclerosus. While the exact etiology of LS is as yet unknown, there is at least a suggested genetic component as evidenced by case reports of familial LS, findings of associations with HLA antigens, and high rates of concordance with other autoimmune disorder.

The purpose of this study is to determine the differences in the genomic/proteomic profiles between LS and normal skin biopsies for women with active vulvar lichen sclerosus in order to identify potential biomarkers that can be used for the prevention, early diagnosis and effective treatment for LS. The study will aim to identify genes/proteins/glycoproteins biomarkers that are associated with LS, select biomarkers associated with LS either individual candidate biomarker or as a panel, validate the identified candidate biomarkers for LS using targeted analysis of candidate biomarkers from independent LS specimen sets, develop assays to determine the clinical utilities of the identified biomarkers as minimum invasive tests for the early detection of LS and determine the clinical utility of biomarkers for biopsy-based tissue tests for LS diagnosis and treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03561428
Study type	Observational
Source	Center for Vulvovaginal Disorders
Contact	Andrew T Goldstein, MD
Phone	4102790209
Email	obstetrics@yahoo.com
Status	Recruiting
Phase
Start date	November 27, 2017
Completion date	November 26, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03063684` - Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus	N/A
Completed	`NCT00393263` - Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus	Phase 2
Recruiting	`NCT05010421` - Laser vs Clobetasol for Lichen Sclerosus	Phase 3
Completed	`NCT05593445` - A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus	Phase 2
Recruiting	`NCT06135402` - Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus	N/A
Completed	`NCT02794363` - Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus	N/A
Terminated	`NCT02880904` - Vulvar Scarring Grading Scale for Lichen Sclerosus
Active, not recruiting	`NCT04073082` - Safety and Efficacy of Laser Therapy in Gynaecology
Completed	`NCT03419377` - Lichen Sclerosus - the Influence on Quality of Life	N/A
Completed	`NCT05396261` - a Flexible Wound Dressing for the Management of Genital Skin Conditions	N/A
Active, not recruiting	`NCT03525522` - Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus	N/A
Recruiting	`NCT05671263` - Genital Lichen Sclerosus - Epidemiology, Comorbidities and the Role of Vulvar and Penile Microbiome
Completed	`NCT02732145` - Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis	N/A
Completed	`NCT03665584` - MonaLisa Touch Laser for the Treatment of Vulvar Lichen Sclerosus	N/A
Suspended	`NCT02223975` - Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease	N/A
Terminated	`NCT02881229` - Vulvar Mucosal Specialty Clinic Chart Review

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.