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 not completely relieve the symptoms associated with lichen sclerosus.

The experimental product is a proprietary formulated silicone-based gel called StrataMGT, which may reduce the severity of symptoms associated with lichen sclerosus. StrataMGT lightly bonds to form a protective layer that is waterproof but lets in gas, and hydrates and protects tissue.

The aim of the study is to test the effectiveness of StrataMGT, the experimental product, for the improvement in symptoms associated with lichen sclerosus as measured by three questionnaires that you will take four times during the study.

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

Qualified individuals may contact Research.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?

*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**

IncobotulinumtoxinA is an approved injected medication for several conditions that involve muscle overactivity, but its use for vulvar pain (vulvodynia) is experimental. This is a research study to learn whether this drug can safely and effectively reduce vulvar pain in people with provoked vestibular pain that may be caused by tight pelvic floor muscles.

Participants will initially be randomly assigned to receive either IncobotulinumtoxinA or placebo injections. The placebo injection does not contain any active medication. However, those women who initailly received placebo will later be given the opportunity to receive the study medication at no cost while being monitored by the study physician.

This trial is only taking place at our offices in NY and DC. There are no other locations that are offering the ability to participate in this study.

EMAIL US IF INTEREST IN JOINING: RESEARCH.CVVD@GMAIL.COM