NCT03561428

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2019

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

January 2, 2018

Last Update Submit

June 17, 2018

Conditions

Lichen Sclerosus

Keywords

lichen sclerosus

Outcome Measures

Primary Outcomes (3)

  • Differential gene expression between LS and normal vulvar skin tissue

    Gene expression obtained from biopsies via Next Generation Sequencing (RNASeq)

    1-2 year

  • Differential protein expression between LS and normal vulvar skin tissue

    Protein expression obtained from biopsies via Western blot

    1-2 year

  • Identification of tissue-derived glycoproteins in serum

    Glycoproteins identified via glycoproteomic technologies

    1-2 years

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The total number of subjects to expected to be recruited are 58 total. * six families with 2-3 family members affected in each family with LS * 40 patients (sporadic) with active lichen sclerosus

You may qualify if:

  • of age
  • Diagnosis of active, Histologically proven, vulvar lichen sclerosus

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Centers for Vulvovaginal Disorders

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

All samples obtained in this study will be processed for RNA, protein and DNA extraction, which will be used for gene expression analysis. The samples collected will be snap-frozen in liquid nitrogen before transporting, and store in a -80C degree freezer in the Department of Medicine at the George Washington University School of Medicine in Ross Hall for a period of 5 years for further verification studies if needed, and then they will be destroyed unless the patient has consented to future research on their samples. The patient's name will not be on these specimens, but will instead be given a study number.

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus

Condition Hierarchy (Ancestors)

Lichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Charles Macri, MD

    George Washington University School of Medicine and Health Sciences

    PRINCIPAL INVESTIGATOR

  • Sidney Fu, MD, PhD

    George Washington University School of Medicine and Health Sciences

    PRINCIPAL INVESTIGATOR

  • Andrew T Goldstein, MD

    The Center for Vulvovaginal Disorders

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew T Goldstein, MD

CONTACT

4102790209obstetrics@yahoo.com

Charles Marci, MD

CONTACT

202-741-2510

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Investigator

Study Record Dates

First Submitted

January 2, 2018

First Posted

June 19, 2018

Study Start

November 27, 2017

Primary Completion

November 26, 2019

Study Completion

November 26, 2019

Last Updated

June 19, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

The data will be summarized in publication and presentation. Individual results will not be communicated, and nor the study participants will be contacted about their results.

Locations

US(1)