Safety and Effectiveness of Fractional 2940 nm Laser Treatment for Vulvar Lichen Sclerosus in Adult Women

What this Trial Is About

This clinical trial studies fractional ablative laser treatment for women with Lichen Sclerosus lesions. It aims to evaluate the safety and effectiveness of a 2940 nm fractional laser device in treating these lesions. The study focuses on women aged 18 years or older who have biopsy-proven vulvar lichen sclerosus and symptoms such as dryness, itching, burning, bleeding, blistering, soreness, bruising, tearing, ulcerated lesions, or painful intercourse. Participants are randomly assigned to one of two groups one receiving the fractional 2940 nm laser treatment combined with platelet-rich plasma PRP, and the other receiving the laser treatment alone. The treatments are delivered using the fractional laser device, and the study compares these two approaches to assess their effects. The study does not mention specific dosing schedules but involves follow-up visits and assessments. Throughout the study, participants will undergo various evaluations including clinical photographs and ultrasound imaging of the treatment area. Researchers will measure histological clearance of the lesions at 16 weeks as the primary outcome. Participants must be able to follow the treatment and follow-up schedule and provide informed consent. Safety monitoring includes exclusion of participants with infections or conditions that may affect wound healing, and pregnancy testing before enrollment. The study duration extends to at least 16 weeks for primary outcome assessment.

Laser Treatment for Lichen Sclerosus