The following video explains the history and some of the logic of this research…now open for the enrollment of 30 women suffering with lichen sclerosus (free treatment for those who qualify)….
Here’s the official details of the study as approved by the Institutional Review Board….
You are being contacted because have expressed interest in participating in a research trial using Platelet-rich plasma (PRP) for the skin disease lichen sclerosus. 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. As the PRP is prepared from your own blood, there are no risks of allergic reactions, transfusion reactions, or infections (HIV, Hepatitis, etc).
We will be enrolling 30 women with active, biopsy proven, lichen sclerosus. This is a placebo-controlled study so you will have a 66.6% chance of getting the PRP and 33.3% chance to get the placebo. Neither you, nor the study doctor, will know if you will get the PRP or placebo. The study is only being conducted at the Center for Vulvovaginal Disorders in Washington, DC. There will be 4 study visits in a 14 weeks period. Small biopsies will be performed at the beginning and end of the study. PRP will be injected in areas of active lichen sclerosus two times during the study. No additional treatments will be allowed for 12 weeks prior to enrolling in the study and during the 14 weeks of the study. No compensation will be provided for participation in the trial.
Please read the informed consent at www.CVVD.org/research_studies very carefully before contacting Leia Mitchell at DRG.CVVD@gmail.com. Please be aware that the Center for Vulvovaginal Disorders is the only center conducting this study and its only being conducted in our Washington DC office. If you cannot travel to Washington DC for the 4 visits, you will not be able participate in this study. It is also possible that you may have to come in prior to the study for one visit to confirm that you have active lichen sclerosus. Lastly, we cannot give you referrals for treatment by other physicians.
Sincerely,
Ms. Leia Mitchell
The Center for Vulvovaginal Disorders
If interested in participating in this current project (only 30 will be accepted) then do 3 things…
1. If you have lichen sclerosus and can travel to this address 4 times (click to see where you’ll be going), then fill out the following form (this is password protected in a HIPPA compliant encrypted server. Only Dr. Runels, Dr. Goldstein, and his staff have access to the data)…
2. Click to read the consent form <–
3. Send an email to the following address…
drg.cvvd@gmail.com
If interested in participating in future research with lichen sclerosus or other female sexual dysfunctions, or in being kept up to date about result, then fill out the following form….
Thank you very much for your trust,
Charles Runels, MD
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