Clinical Trial to Demonstrate That the Dual Laser Therapy is Effective for the Treatment of Vulvar Lichen Sclerosus

Prospective, Randomized, Active-controlled Investigator Initiated Clinical Trial to Demonstrate That the Nd:YAG/Er:YAG Dual Laser Therapy is Effective to Treat Vulvar Lichen Sclerosus and Similar to Standard Treatment With Steroid Cream

The aim of this study is to test a new, minimally invasive dual laser technique to treat vulvar lichen sclerosus. Efficacy and safety of the thermal non-ablative Nd:YAG laser and the ablative Er:YAG laser is determined and compared to the current standard treatment with high dose steroids. The hypothesis is that laser therapy is effective and similar to standard steroid therapy.

Lichen sclerosus (LS) is a chronic inflammatory skin disease that usually involves the anogenital area where it causes itching and burning pain, pain during sexual intercourse, and anal or genital bleeding due to fissuring of the damaged tissue. In this study a treatment with dual laser application combining thermal non-ablative Nd:YAG with ablative Er:YAG laser is used to reduce the symptoms of LS. Results will be compared to the standard therapy with topical steroid cream.

Inclusion criteria:

• Diagnosis of vulvar lichen sclerosus
• Clinical LS score ≥ 4

Exclusion criteria:

• Concomitant steroid, calcineurin inhibitor or any other topical or systemic treatment for LS
• < 3 months since start of vaginal estrogen treatment
• Malignant disease as the cause of the vulval symptoms
• BMI > 35 kg/m²
• Acute infection (fungal, bacterial, viral) of the vulva, vagina or bladder
• Presence of contraindications for the laser treatment or topical steroid treatment