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NCT03045172 · ClinicalTrials.gov registry record · NA
Platelet Rich Plasma (PRP) for Vulvar Lichen Sclerosus
A NA study of Lichen Sclerosus of Vulva, sponsored by Center for Vulvovaginal Disorders.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT03045172 is a NA study of Lichen Sclerosus of Vulva that has completed, run by Center for Vulvovaginal Disorders. The registered enrollment target is 29 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03045172, a NA study of Lichen Sclerosus of Vulva, has completed, sponsored by Center for Vulvovaginal Disorders.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop vulvar cancer. The current "gold standard" treatment for lichen sclerosus is potent steroids creams. When used correctly, steroid creams help to decrease the symptoms of itching and burning and can prevent further vulvar scarring. In addition, proper treatment reverses the underlying inflammation of LS, and may lower the risk of getting cancer. While useful, steroid creams may have serious side effects that include thinning of the skin, fungal infections, and lowering the immune system. Platelet-rich plasma (PRP) is a platelet concentrate that helps to speed up tissue healing, without serious side effects, in a very wide range of medical conditions such as diabetic foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The PRP works because of its high level of proteins that help with wound healing. It is also apparent from the majority of published studies that PRP therapy has minimal risk of scar tissue formation or significant bad side effects. Recently, there was an exploratory study of twelve subjects that used PRP for the study treatment of lichen sclerosus. While this study showed good success, the study was limited because of its small size and lack of placebo (a drug or study treatment that contains no active ingredient) control.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Platelet Rich Plasma
Study Locations (1)
District of Columbia
- The Center for Vulvovaginal Disorders - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2016-11 |
| Est. Completion | 2018-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03045172
The ClinicalTrials.gov registry entry for NCT03045172 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Center for Vulvovaginal Disorders, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lichen Sclerosus of Vulva appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03045172 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.
Frequently Asked Questions
What is clinical trial NCT03045172 about?
NCT03045172 is a clinical study titled "Platelet Rich Plasma (PRP) for Vulvar Lichen Sclerosus". Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop vulvar cancer. The curren...
What is the current status of trial NCT03045172?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2016-11. Estimated completion is 2018-10.
What conditions does trial NCT03045172 study?
This clinical trial studies the following conditions: Lichen Sclerosus of Vulva.
What interventions are being tested in trial NCT03045172?
The interventions under investigation include: Placebo (DRUG), Platelet Rich Plasma (BIOLOGICAL).
Who is sponsoring clinical trial NCT03045172?
This trial is sponsored by Center for Vulvovaginal Disorders, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03045172 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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