NCT03926299

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Prof. Dr. Volker Viereck · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Skin Disease
• Vulvar Lichen Sclerosus

Interventions

Type	Name	Description
DEVICE	FotonaSmooth SP® Spectro laser device	dual laser treatment with thermal Nd:YAG and ablative Er:YAG (Fotona medical device), 4 laser sessions 4-8 weeks apart.
DRUG	Clobetasol propionate 0.05% ointment	6 months standard treatment with topical steroid cream (high dose for the first two months, medium dose for the next two months, low dose for the last two months)

Timeline

• Start date: 2019-07-15
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2019-04-24
• Last updated: 2026-03-23

Locations

1 site across 1 country: Switzerland