TerminatedNot Applicable

Laser Treatment for Vulvar Lichen Sclerosus

Stopped: Recruitment was significantly impacted by the COVID-19 pandemic.

United States15 participantsStarted 2020-01-01

Plain-language summary

The object of this non-randomized, prospective study is to assess the effectiveness of ablative fractional 2940 nm laser treatment of vulvar lichen sclerosus. Aim 1: To assess physical and histological changes related to vulvar lichen sclerosus before and after laser treatment. Aim 2: To evaluate participant satisfaction for laser treatment of vulvar lichen sclerosus. The results of this study will determine whether fractional 2940 nm laser is an effective treatment option for lichen sclerosus, particularly for those participants not eligible for high-dose topical steroids or who have failed prior treatment with topical steroids.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

We are currently recruiting Massachusetts residents only due to COVID-19. Inclusion Criteria: * Female * Aged 18 years old or older * Biopsy-proven active vulvar lichen sclerosus * Characteristic changes of vulvar lichen sclerosus on gynecological exam * Self-reported indication of one or more of the following symptoms of lichen sclerosus * Dryness * Itching * Burning * Bleeding * Blistering * Soreness * Easily bruises * Easily tears * Ulcerated lesions * Painful intercourse * Ability to complete questionnaires in English * Written, informed consent * Willing and able to logistically follow schedule of treatments and follow-up visits Exclusion Criteria: * Receiving systemic immunosuppressant's (e.g. corticosteroids) within 4 weeks of enrollment * Use of topical vulvar steroid-containing creams at the affected area within 4 weeks of enrollment * Immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome) * History of uncontrolled malignant disease * Additional genital skin disease * Known allergy or intolerance to topical anesthesia * Known history of connective tissue disease * Known propensity for keloid formations

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Depth of Disease From Baseline to Three Months After the Last Laser Treatment

Timeframe: From enrollment to 3 months after the last laser treatment

Trial details

NCT IDNCT04134494

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-27

Results submitted2023-07-14

View on ClinicalTrials.gov More Vulvar Lichen Sclerosus trials