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Clinical trial

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

ID
Name
Lichen sclerosus laser study
Description
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.
Trial arms
Trial start
2019-07-15
Estimated PCD
2024-05-30
Trial end
2024-07-30
Status
Active (not recruiting)
Treatment
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.
Arms:
Laser
Other names:
Laser therapy
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)
Arms:
Topical steroid
Other names:
Local steroid therapy
Size
66
Primary endpoint
Clinical Lichen sclerosus score (LS score)
6 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, active-controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}
Updated at
2024-01-18

1 organization

1 product

2 indications

Organization
Prof. Dr. Volker Viereck
Product
Clobetasol propionate
Indication
Chronic skin disease
Indication
Vulvar Lichen Sclerosus