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NCT05147129 · ClinicalTrials.gov registry record
Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus
A clinical trial, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- 17
- Enrollment target
NCT05147129: Completed study, sponsored by University of Texas Southwestern Medical Center.
NCT05147129 is a clinical trial that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05147129 has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
Similar 16s sequencing reads will be clustered into OTUs and relative abundance of OTUs in the samples under investigation will be reported
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-09-16 |
| Est. Completion | 2022-07-30 |
What the finished NCT05147129 record still lists
NCT05147129 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05147129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05147129 about?
NCT05147129 is a clinical study titled "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 conditio...
What is the current status of trial NCT05147129?
This trial is currently completed. The enrollment target is 17 participants. The study started on 2021-09-16. Estimated completion is 2022-07-30.
Who is sponsoring clinical trial NCT05147129?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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