Laser Treatment for Vulvar Lichen Sclerosus
Stopped early · Not applicable
Conditions studied: Vulvar Lichen Sclerosus
In brief
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.
Key facts
- Study ID
- NCT04134494
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 15
- Starts
- 2020-01-01
- Expected to finish
- 2022-12-31
- Last updated by the study team
- 2024-06-05
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- BIDMC — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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