Status:
TERMINATED
Laser Treatment for Vulvar Lichen Sclerosus
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Sciton
Conditions:
Vulvar Lichen Sclerosus
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 histologic...
Detailed Description
This will be a non-randomized, open-label, prospective study. Participants will be recruited in general and subspecialty obstetrics and gynecology clinics. Participants who meet all eligibility criter...
Eligibility Criteria
Inclusion
- We are currently recruiting Massachusetts residents only due to COVID-19.
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04134494
Start Date
January 1 2020
End Date
December 31 2022
Last Update
June 5 2024
Active Locations (1)
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1
BIDMC
Boston, Massachusetts, United States, 02115