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

Prof. Dr. Volker Viereck

Status

Active, not recruiting

Conditions

Chronic Skin Disease

Vulvar Lichen Sclerosus

Treatments

Drug: Clobetasol propionate 0.05% ointment

Device: FotonaSmooth SP® Spectro laser device

Study type

Interventional

Funder types

Other

Identifiers

NCT03926299

Lichen sclerosus laser study

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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