Lichen sclerosus is a skin condition of the external genitals (vulva) of women. Lichen sclerosus causes vulvar itching, pain, and burning. In addition, lichen sclerosus causes scarring of the vulva which may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with lichen sclerosus will develop vulvar cancer.

The current “gold standard” treatment for lichen sclerosus is potent steroid 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 lichen sclerosus, and may lower the risk of getting cancer. While useful, steroid creams may have side effects that include thinning of the skin, fungal infections, and lowering the immune system.

This research study is for StrataMGT, the study regimen for lichen sclerosus. It is not known if this study regimen will be an effective (good) for lichen sclerosus.

You may not use additional medications for lichen sclerosus while participating in this study.

The experimental product is a proprietary formulated silicone-based product that may reduce the severity of lichen sclerosus.

The aim of the study is to test the effectiveness of StrataMGT, an experimental product for lichen sclerosus by assessing the reduction in inflammation associated with lichen sclerosus as well as the reduction in symptoms of lichen sclerosus.

Open and currently enrolling! To see if you qualify, please click here to review Informed Consent!

Qualified individuals may contact Leia at Research1.cvvd@gmail.com

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.

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

Please click here to read our study results/finding.

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. Additional questions? Email drg.cvvd@gmail.com

STATUS: OPEN, Currently enrolling

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.

STATUS: CLOSED, please see our publications section for more information.

A phase II, multicenter, double-blind, randomized, placebo-controlled, dose escalation and dose finding study to evaluate the efficacy and safety of Dysport in vulvodynia patients.

The purpose of this research study is the evaluate the efficacy, safety and identify the optimal doses of Dysport in the treatment of vulvodynia. In this study, Dysport will be compared to a placebo treatment.

Dysport was first approved in the United Kingdom (UK) in 1990 and is now approved in more than 85 countries including the United States (US), for the treatment of conditions where muscle needs to relax.

Other studies done with Dysport or other Botulinum toxin A for vulvodynia and other related conditions (like vaginismus), have show to relax the pelvic floor muscles and decrease pain.

Status: CLOSED