Biomarkers of Lichen Sclerosus

Status unconfirmed

Conditions studied: Lichen Sclerosus

In brief

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.

Key facts

Study ID

NCT03561428

Run by

Center for Vulvovaginal Disorders

People needed

58

Starts

2017-11-27

Expected to finish

2019-11-26

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 18-75 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.

Where it is running

• The Centers for Vulvovaginal Disorders — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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