Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus

Study Overview
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Brief Summary
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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.

Official Title
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Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus

Conditions
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Vulvar Lichen Sclerosus

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postmenopausal with vulvar lichen sclerosus<br>Includes postmenopausal patients with clinically-active vulvar lichen sclerosus, as determined by biopsy or examination by a vulvar specialist | |
| Postmenopausal without vulvar lichen sclerosus<br>Includes postmenopausal patients without vulvar lichen sclerosus | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operational taxonomic unit (OTU) relative abundance | Similar 16s sequencing reads will be clustered into OTUs and relative abundance of OTUs in the samples under investigation will be reported | Baseline | 
| Operational taxonomic unit (OTU) relative abundance | Similar 16s sequencing reads will be clustered into OTUs and relative abundance of OTUs in the samples under investigation will be reported | 10-14 weeks after beginning treatment for vulvar lichen sclerosus, if applicable | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alpha and beta diversity | Alpha and beta diversity will be estimated in the context of sample metadata | Baseline | 
| Alpha and beta diversity | Alpha and beta diversity will be estimated in the context of sample metadata | 10-14 weeks after beginning treatment for vulvar lichen sclerosus, if applicable |