Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus

Study Overview
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Brief Summary
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This study evaluates the efficacy of Nd:Yttrium Aluminum Garnet Laser (Nd:YAG) Treatment of Lichen sclerosus in comparison with topical corticosteroid treatment. Half of participants will receive laser treatment and the other half corticosteroid treatment and the results will be followed for 6 months.

Detailed Description
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Lichen sclerosus (LS) is a chronic skin disease of unknown cause and very unpleasant symptoms which significantly influences the quality of life of the affected patients. Large majority of LS lesions is located in anogenital region where initial white flat papules usually develop into large, white patches of thin, itchy skin causing fusion of labia minora, narrowing of the introitus and burying of the clitoris. Most common symptoms are itching, pain, soreness, burning, dyspareunia and dysuria all strongly interfering with sexual function and patient's self image. Existing treatment options with systemic and topical medications (oral retinoids, topical steroids) have some drawbacks and recently the use of laser was proposed for treatment of LS. This study evaluates the safety and efficacy of Nd:Yttrium Aluminum Garnet Laser (Nd:YAG) Treatment of Lichen sclerosus in comparison with topical corticosteroid treatment. Half of participants will receive laser treatment and the other half corticosteroid treatment and the results will be followed for 6 months.

Official Title
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Efficacy of Nd:Yttrium Aluminum Garnet Laser Treatment of Lichen Sclerosus

Conditions
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Lichen Sclerosus, Lichen Sclerosus Et Atrophicus

Intervention / Treatment
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* Device: Nd:YAG Laser
* Drug: Topical corticosteroid Diprosone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed Lichen sclerosus voluntary signed informed consent Exclusion Criteria: pregnancy use of photosensitizing medication pathology other than Lichen damage of tissues in the treatment area other inflammation refusal to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients assigned randomly to two groups: laser-treatment group and topical-corticosteroid group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nd:YAG Laser<br>Three sessions of Nd:YAG laser (1064 nm) treatment with Dynamis (Fotona, Slovenia) | Device: Nd:YAG Laser<br>* Three sessions of Nd:YAG treatment every two weeks.<br>* Other names: Dynamis;|
| Active Comparator: Topical Corticosteroid Diprosone<br>Topical corticosteroid betamethasone (Diprosone, Merck Sharp & Dohme, d.o.o.) for 3 months. | Drug: Topical corticosteroid Diprosone<br>* 3 months of topical corticosteroids Diprosone<br>* Other names: topical corticosteroids betamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months | Patients will evaluate symptoms on a 0-10 VAS scale | Change from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual analog scale (VAS) score symptom evaluation from baseline to 1 month | Patients will evaluate symptoms on a 0-10 VAS scale | Change from baseline to 1 month | 
| Change in Visual analog scale (VAS) score symptom evaluation from baseline to 6 months | Patients will evaluate symptoms on a 0-10 VAS scale | Change from baseline to 6 months | 
| Comparative histological evaluation | biopsies taken at baseline and after treatment | baseline and 3 months | 
| patient satisfaction | Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale. | 1 month | 
| patient satisfaction | Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale. | 3 months | 
| patient satisfaction | Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale. | 6 months | 
| evaluation of improvement from clinical photographs | by blinded evaluators on a 1-4 scale | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lichen sclerosus, laser, Nd:YAG, randomized controlled trial