Patients with Lichen Sclerosus (LS) currently have limited treatment options, which include irritant avoidance and first-line treatment with topical corticosteroids. Topical calcineurin inhibitors are the second line of choice when topical corticosteroids are not effective or not tolerated. Ruxolitinib is a small molecule inhibitor of the JAKs, which play an important role in turning down genes associated with chronic inflammatory conditions, including atopic dermatitis, vitiligo, and other autoimmune diseases of the skin. Similar to atopic dermatitis and vitiligo, LS is considered to be an inflammatory dermatosis, and based on Ruxolitinib’s demonstrated efficacy in both AD and vitiligo in well-designed pivotal Phase 3 trials, Ruxolitinib 1.5% cream is expected to have potential activity in LS.

We will be enrolling women with active, biopsy proven, Lichen Sclerosus in a phase 2, randomized, double-blind, vehicle-controlled, study of the efficacy and safety of Ruxolitinib cream. Our study site is located at the Center for Vulvovaginal Disorders in Washington, DC, and participants must be located within a 50-mile radius of our center or be willing to travel. This is a double-blind placebo control study, meaning the first half of the study, half of the participants will receive the medication cream and the other half will get the placebo cream. In the second half of the study, all participants will be given the medication cream. There will be 10 study visits in a 34-week period. Small biopsies will be performed at the initial screening visit, end of first phase of trial, and end of second phase of trial. Please note we use numbing medication and close our biopsy sites to ensure a pleasant process and recovery for all participants. The Ruxolitinib 1.5% cream or vehicle cream will be applied in areas of active Lichen Sclerosus twice a day throughout the study, unless otherwise specified by our physicians. No additional treatments of Lichen Sclerosus will be allowed for two weeks prior to enrolling in the study and during the 34 weeks of the study. Participants who fully complete the study (fill out all e-Diaries and attend all 10 visits) will be compensated at the end.

If you are interested in participating, please email sylvia.cvvd@gmail.com and jess.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.

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

*If you are a well-qualified candidate as per the informed consent, please complete the following form: https://www.surveymonkey.com/r/YTDBRTJ

STATUS: CLOSED

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