An observational study in Vulvar Lichen Sclerosus, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2022-08-31.
Sponsored by University of Texas Southwestern Medical Center · Observational
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.
36 studies on the registry are indexed under Vulvar Lichen Sclerosus; 10 are open to participants now.
Browse Vulvar Lichen Sclerosus studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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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
Exclusion Criteria:
Includes postmenopausal patients with clinically-active vulvar lichen sclerosus, as determined by biopsy or examination by a vulvar specialist
Includes postmenopausal patients without vulvar lichen sclerosus
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
Time frame: 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
Time frame: 10-14 weeks after beginning treatment for vulvar lichen sclerosus, if applicable
Alpha and beta diversity
Alpha and beta diversity will be estimated in the context of sample metadata
Time frame: Baseline
Alpha and beta diversity
Alpha and beta diversity will be estimated in the context of sample metadata
Time frame: 10-14 weeks after beginning treatment for vulvar lichen sclerosus, if applicable
Plan to share: No
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center