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

What/How?

Ketotifen fumarate is a topical medication used to reduce nerve sensitivity and inflammation. It was recently identified by a group of vulvodynia experts as the best option to research for treatment of provoked nerve pain at the vulvar vestibule.

The purpose of this study is to evaluate the safety and effectiveness of ketotifen fumarate 0.25% cream for treating vestibular nerve pain. The study will include 4 clinic visits over an approximately 15-week period. This will include the following:

1-week screening period 2-week pre-study drug regimen period 12-week study drug regiment period Brief safety follow-up 1 month after last use of study cream.

Participants will be randomly assigned to receive either ketotifen fumarate cream or a placebo cream to use throughout the study.

Who?

*Female participants ≥18 years of age

*Have nerve-related pain of the vestibule (vestibulodynia)

*Report >6 months of pain with insertional intercourse, pain with tampon insertion, or pain to touch

*Demonstrate moderate to severe tenderness at the vestibule on exam

*Are willing to attend all study visits and apply your assigned study cream as instructed

PLEASE NOTE: Study is only being conducted at our offices in NY, DC, and FL

Email us if interest in joining!

research.cvvd@gmail.com

**A Centers for Vulvovaginal Disorders study sponsored by National Vulvodynia Association and Gynecologic Cancers Research Foundation**