Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus

NCT05147129 | Completed

• 1 other identifier: STU2021-0392
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vulvar Lichen Sclerosus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Alpha and beta diversity

  Baseline

• Alpha and beta diversity

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

Study Arms (2)

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

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Postmenopausal

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Dermatology Foundation: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (4)

• 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.

  PMID: 26070005 BACKGROUND

• 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.

  PMID: 33015282 BACKGROUND

• 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.

  PMID: 31712170 BACKGROUND

• 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.

  PMID: 33444404 BACKGROUND

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Melissa M Mauskar, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: December 7, 2021
• Study Start: September 16, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)