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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03926299
Recruitment Status Recruiting
First Posted April 24, 2019
Last update posted July 24, 2019
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.
dual Fotona laser treatment (Nd:YAG and Er:YAG)
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.
|Active Comparator: Topical steroid
clobetasol propionate 0.05% cream
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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Diagnosis of vulvar lichen sclerosus
- Clinical LS score ≥ 4
- Concomitant steroid, calcineurin inhibitor or any other topical or systemic treatment
- 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
Contact: Volker Viereck, Prof. +41 52 723 7050 email@example.com
Cantonal Hospital Frauenfeld
Prof. Dr. Volker Viereck
Principal Investigator: Volker Viereck, Prof. Department of Gynecology and Obstetrics