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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Dr. Volker Viereck
• Treatments: Clobetasol

Criteria

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