drugset / Trial / NCT03926299
Clinical Trial to Demonstrate That the Dual Laser Therapy is Effective for the Treatment of Vulvar Lichen Sclerosus
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-07-15
- Primary completion
- 2024-07-30
- Completion
- 2024-07-30
Publications
- Gamper M, Zivanovic I, Bischofberger H, Viereck V. One-year outcome after laser treatment of vulvar lichen sclerosus: a prospective observational trial. Arch Gynecol Obstet. 2026 Jul 1. doi: 10.1007/s00404-026-08510-3. Online ahead of print.
- Zivanovic I, Gamper M, Fesslmeier D, Bischofberger H, Viereck V. A randomized controlled trial to evaluate a novel dual laser therapy for vulvar lichen sclerosus: exploratory study assessing the impact of menopausal status. Menopause. 2025 Mar 1;32(3):228-233. doi: 10.1097/GME.0000000000002478. Epub 2025 Feb 21.
- Viereck V, Gamper M, Regauer S, Walser C, Zivanovic I. Nd:YAG/Er:YAG dual laser vs. topical steroid to treat vulvar lichen sclerosus: study protocol of a randomized controlled trial. Arch Gynecol Obstet. 2023 Aug;308(2):643-649. doi: 10.1007/s00404-023-07055-z. Epub 2023 May 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | clobetasol propionate | Small molecule | 0.05 % | Topical |