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.

Study Overview

• Status: Completed
• Conditions: Vulvar Lichen Sclerosus

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Group - Postmenopausal with vulvar lichen sclerosus: selected from patients presenting to vulvar dermatology clinic

Group - Postmenopausal without vulvar lichen sclerosus: selected from dermatology or gynecology clinics

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Postmenopausal with vulvar lichen sclerosus; Includes postmenopausal patients with clinically-active vulvar lichen sclerosus, as determined by biopsy or examination by a vulvar specialist
Postmenopausal without vulvar lichen sclerosus; Includes postmenopausal patients without vulvar lichen sclerosus

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Dermatology Foundation
• Investigators: Principal Investigator: Melissa M Mauskar, MD, University of Texas Southwestern Medical Center

Publications and helpful links

General Publications

• Lee A, Bradford J, Fischer G. Long-term Management of Adult Vulvar Lichen Sclerosus: A Prospective Cohort Study of 507 Women. JAMA Dermatol. 2015 Oct;151(10):1061-7. doi: 10.1001/jamadermatol.2015.0643.
• Melnick LE, Steuer AB, Bieber AK, Wong PW, Pomeranz MK. Lichen sclerosus among women in the United States. Int J Womens Dermatol. 2020 May 8;6(4):260-262. doi: 10.1016/j.ijwd.2020.05.001. eCollection 2020 Sep.
• Mauskar MM, Marathe K, Venkatesan A, Schlosser BJ, Edwards L. Vulvar diseases: Conditions in adults and children. J Am Acad Dermatol. 2020 Jun;82(6):1287-1298. doi: 10.1016/j.jaad.2019.10.077. Epub 2019 Nov 8.
• Chattopadhyay S, Arnold JD, Malayil L, Hittle L, Mongodin EF, Marathe KS, Gomez-Lobo V, Sapkota AR. Potential role of the skin and gut microbiota in premenarchal vulvar lichen sclerosus: A pilot case-control study. PLoS One. 2021 Jan 14;16(1):e0245243. doi: 10.1371/journal.pone.0245243. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Vulvar Diseases; Lichenoid Eruptions; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
• Other Study ID Numbers: STU2021-0392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No