Clinical trial NCT05147129: Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus
Official title: Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvar Lichen Sclerosus
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Dermatology Foundation
First posted: 2021-12-07
Enrollment: 17
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Operational taxonomic unit (OTU) relative abundance
timeFrame: Baseline
measure: Operational taxonomic unit (OTU) relative abundance
timeFrame: 10-14 weeks after beginning treatment for vulvar lichen sclerosus, if applicable
Secondary outcomes:
measure: Alpha and beta diversity
timeFrame: Baseline
measure: Alpha and beta diversity
timeFrame: 10-14 weeks after beginning treatment for vulvar lichen sclerosus, if applicable
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Melissa M Mauskar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.