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.
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)…
Here’s an example of what is possible using O-Shot® methodology to treat lichen sclerosus. These photos are courtesy of Dr. Red Alinsod, who also enjoys a world-wide reputation for labial surgeries and is expert at freeing the phimosis that can happen with the clitoral hood.
If you (or someone you love) suffers with lichen, then we will keep you updated with future research if you will give us your information on the following form (your information will not be shared). We will also send to you information occasionally about research that concerns vaginal and sexual health that may relate to subjects other than lichen (but which will be of importance to all women).
Because of the sexual nature of the emails (using words like “vagina” and displaying photos of the vagina) the spam filters will capture all of the communications to you unless you confirm that you wish to receive the information by clicking on the email that will be sent to you (which may also be in your spam folder).
I hope and pray that we can eventually eliminate this horrible disease from the planet. Please help us in our quest by helping spread the word and by giving us your feed back.
Patient Reviews (click)<–
Here’s the form that allows us to keep you up-to-date and let you know about future research.
All we really need is first name and email, but if you supply more it will help us identify you as a candidate for future research participation…
Dr. Runels talks about using the O-Shot® method to help with urinary incontinence at the Biobridge Conference in Venice Italy (sponsored by Regen PRP).
In the following video, the photos of the hand are courtesy of Mark Lowney, MD, FACOG & the lichen photos are courtesy of Kathleen Posey, MD, FACOG. The lichen study was done with the leadership of Dr. Andrew Goldstein, MD, FACOG.