Vulvar Lichen Sclerosus: Comparing Inflammatory Markers After Treatment With Clobetasol Ointment or Fractional CO2 Laser in Women Without Prior Corticosteroid Therapy

What this Trial Is About

Researchers are evaluating treatments for vulvar lichen sclerosus, a chronic inflammatory condition affecting the vulvar skin, mainly in peri- and post-menopausal women. The study compares clobetasol ointment, the standard treatment, to fractional CO2 laser therapy. This condition causes symptoms like itching, pain during intercourse, and vulvar pain, and if untreated, can lead to vulvar distortion and a small risk of cancer. The study aims to understand if the laser treatment can reduce inflammation and symptoms as an alternative to clobetasol. Participants are randomly assigned to one of two treatment groups. One group applies clobetasol propionate 0.05% ointment daily for the first month, every other day in the second month, and twice weekly in the third month. The other group receives three sessions of fractional microablative CO2 laser treatment spaced four weeks apart, with an anesthetic ointment applied before each session. After each laser session, participants follow care instructions such as avoiding sexual intercourse for five days. Participants will have a biopsy at the start and three months after completing treatment to measure inflammatory biomarkers. Researchers will assess symptom changes including itching, pain, vulvar appearance, and satisfaction using questionnaires and visual scales. The study monitors participants from registration through treatment and three months post-treatment to evaluate the effects and safety of both therapies.

To Compare Inflammatory Biomarkers Before and After Treatment With Clobetasol or Fractional CO2 Laser, in Women With Histologically Confirmed Vulvar Lichen Sclerosus, Without Prior Corticosteroid Treatment.