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 range18 Years

SexFEMALE

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

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

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