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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: Completed NA study of Lichen Sclerosus of Vulva, sponsored by Center for Vulvovaginal Disorders.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A validated instrument that assesses both the investigator's impression of the severity of disease and a patient's impression of the severity of her disease pre and post-intervention.
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 |
What the finished NCT03045172 record still lists
NCT03045172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03045172's enrollment target sits among peer trials
29 1702nd of 2000 higher than 297 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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