Laser Treatment for Vulvar Lichen Sclerosus

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Oct 18, 2019

Keywords

ClinConnect Summary

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 criteria, including providing written informed consent, will have three treatment visits and three follow-up visits in an outpatient setting. Participants will not be charged for any treatments.

At each treatment visit, participants will be asked to complete questionnaires to assess their symptoms. The investigators will also take photographs of the affected area at each treatment visit. Photographs...

Gender

FEMALE

Eligibility criteria

• • 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