CompletedNot Applicable

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

Switzerland66 participantsStarted 2019-07-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Lichen sclerosus score (LS score)

Timeframe: 6 months

Trial details

NCT IDNCT03926299

SponsorProf. Dr. Volker Viereck

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-30

View on ClinicalTrials.gov More Chronic Skin Disease trials