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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03561428
Other study ID # 091739
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 27, 2017
Est. completion date November 26, 2019

Study information

Verified date June 2018
Source Center for Vulvovaginal Disorders
Contact Andrew T Goldstein, MD
Phone 4102790209
Email obstetrics@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 58
Est. completion date November 26, 2019
Est. primary completion date November 26, 2019
Accepts healthy volunteers
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 18-75 of age

- Diagnosis of active, Histologically proven, vulvar lichen sclerosus

Exclusion Criteria:

- Under the age of 18 or over the age of 75.

- Participants who are pregnant at the time of recruitment

- If, in the clinical opinion of Dr. Andrew Goldstein, she:

- does not have active LS

- has active infection

- has evidence of any other dermatologic disease of the vulva

- has evidence of neoplastic disease of the vulva

- If, in the opinion of Dr. Andrew Goldstein, they will be unable to keep the biopsy sites clean until they heal.

- If the biopsy specimen sent to dermatopathology is not confirmatory for active lichen sclerosus then the specimens obtained from that patient will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States The Centers for Vulvovaginal Disorders Washington District of Columbia

Sponsors (3)

Lead Sponsor Collaborator
Center for Vulvovaginal Disorders George Washington University, Gynecologic Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differential gene expression between LS and normal vulvar skin tissue Gene expression obtained from biopsies via Next Generation Sequencing (RNASeq) 1-2 year
Primary Differential protein expression between LS and normal vulvar skin tissue Protein expression obtained from biopsies via Western blot 1-2 year
Primary Identification of tissue-derived glycoproteins in serum Glycoproteins identified via glycoproteomic technologies 1-2 years
See also
  Status Clinical Trial Phase
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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

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