Research Studies

The practitioners at The Centers for Vulvovaginal Disorders are strongly committed to research. They have been recipients of grants from The National Vulvodynia Association, The Gynecologic Cancers Research Foundation, and the Catherine Birch McCormick Foundation. Please look below to see our current research opportunities. 

Lichen Sclerosus- Platelet Rich Plasma (PRP)

Genomics and Proteomics of Lichen Sclerosus

Platelet Rich Plasma (PRP) Injections for the Treatment of Female Orgasmic Disorder

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 16,000+ published studies that PRP therapy has almost no risk of scar tissue formation or 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. The study is only being conducted at the Center for Vulvovaginal Disorders in Washington, DC. This is a double-blind placebo control study so 20 women will get the PRP, 10 will get placebo. 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 four 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.

If you have had problems using steroids for your lichen sclerosus, then this may be the ideal treatment for you. Please read the informed consent very carefully before contacting us. 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 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. 

If, after having read the informed consent, you want to participate in the study, please contact Leia Mitchell via E-mail at drg.cvvd@gmail.com. Please give a daytime and evening phone number to be contacted regarding this study.

STATUS: CLOSED. We are no longer accepting candidates for this study.

We are currently conducting a clinical study in women with lichen sclerosus to learn which genes are turned on and which genes are turned off in skin affected by LS as compared to normal skin in order to understand LS, and further to develop effective drugs to treat the condition. This study is only being conducted at the Washington DC office of the Centers for Vulvovaginal Disorders. Click here to read the informed consent to see if you are eligible.  If you are eligible, please email drg.cvvd@gmail.com.

STATUS: OPEN, Currently enrolling

Double Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma (PRP) Peri-urethral and clitoral Injections for the Treatment of Female Orgasmic Disorder

Approximately one in twenty women have Female Orgasmic Disorder (FOD) and it is the second most frequently reported sexual problem in American women. FOD can either be lifelong (primary) or acquired (secondary). 

It has been suggested by many scientists that in some women FOD may be caused by decreased clitoral and genital blood flow secondary to blockage in the small blood vessels going to the clitoris (similar to that seen in erectile dysfunction (ED) in men) and/or diminished nerve conduction (also as seen in ED). PRP activates cells to develop into new tissue—nerves, collagen, and blood vessels. As such, PRP may potentially reverse the changes responsible for FOD. In addition, it has been shown that improved sexual function in women is highly linked with increased blood flow through the clitoris. One component of PRP is known to cause growth of new blood vessels. Therefore, we anticipate PRP injections may potentially improve blood flow through both the clitoris and the tissue around the urethra, thereby improving sexual function and decreasing FOD.  Please review our informed consent here and contact us at drg.cvvd@gmail.com if you are a well-qualified candidate. 

STATUS: Open, not enrolling patients until further notice


Double-Blind, Sham Controlled Trial of Fractional Carbon Dioxide Laser for the Treatment of 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 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.

Recently, microablative fractional CO2 laser treatment (FxCO2) (SmartXide2 V2LR laser system, for MonaLisa Touch, DEKA, Florence, Italy) has been proposed for the management of LS.  Specifically, two small studies demonstrated that FxCO2 therapy appears to be a promising treatment modality to treat lichen sclerosus. These studies demonstrated that FxCO2 treatment may stimulate tissue healing in LS. Furthermore, by reducing inflammation, the clinical symptoms of LS, such as intense itching and burning, were improved. While these studies showed good success, these studies were limited because of their small size and lack of sham (fake treatment) control.

The purpose of this study is to look at the efficacy (how well it works) and the safety of the FxCO2 laser treatment (laser energy emitted) for LS as compared to a sham treatment (very minimal laser energy will be emitted). We will be enrolling up to 40 qualified participants.  

If you are interested in participating, please carefully the informed consent.  

*If you are a well-qualified candidate, please email us at drg.cvvd@gmail.com

HAVE A QUESTION? 

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