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 range18 Years

SexFEMALE

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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

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