Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus

Vulvar Lichen Sclerosus Clinical Trial

Official title:

Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05147129
• Other study ID #: STU2021-0392
• Status: Completed
• Start date: September 16, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: August 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Sclerosus et Atrophicus
• Vulvar Lichen Sclerosus

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Dermatology Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Alpha and beta diversity	Alpha and beta diversity will be estimated in the context of sample metadata	Baseline
Secondary	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