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OpenTrials
Completed

NCT Number: NCT05147129

Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal

Exclusion criteria

  • Use of systemic hormone replacement
  • Use of antibiotics in prior three months
  • Urinary incontinence, which is defined by: 1) two incontinence episodes in the past three days and also 2) regular incontinence over the past three months that has necessitated use of incontinence protection garments

Treatment and study plan

Primary outcomes

  1. Operational taxonomic unit (OTU) relative abundance

    Time frame: Baseline

    Similar 16s sequencing reads will be clustered into OTUs and relative abundance of OTUs in the samples under investigation will be reported

  2. Operational taxonomic unit (OTU) relative abundance

    Time frame: 10-14 weeks after beginning treatment for vulvar lichen sclerosus, if applicable

    Similar 16s sequencing reads will be clustered into OTUs and relative abundance of OTUs in the samples under investigation will be reported

Secondary outcomes

  1. Alpha and beta diversity

    Time frame: Baseline

    Alpha and beta diversity will be estimated in the context of sample metadata

  2. Alpha and beta diversity

    Time frame: 10-14 weeks after beginning treatment for vulvar lichen sclerosus, if applicable

    Alpha and beta diversity will be estimated in the context of sample metadata

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Dermatology Foundation

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 7, 2021
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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