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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Skin Disease, Vulvar Lichen Sclerosus

Intervention / Treatment
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* Device: FotonaSmooth SP® Spectro laser device
* Drug: Clobetasol propionate 0.05% ointment


Participation Criteria
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Eligibility Criteria
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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

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: randomized, active-controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br>dual Fotona laser treatment (Nd:YAG and Er:YAG) | Device: FotonaSmooth SP® Spectro laser device<br>* dual laser treatment with thermal Nd:YAG and ablative Er:YAG (Fotona medical device), 4 laser sessions 4-8 weeks apart.<br>* Other names: Laser therapy;|
| Active Comparator: Topical steroid<br>clobetasol propionate 0.05% cream | Drug: Clobetasol propionate 0.05% ointment<br>* 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)<br>* Other names: Local steroid therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Lichen sclerosus score (LS score) | Reduction (i.e. improvement) of physician administered clinical LS score (Sum score of 6 items on a scale from 0-2 (0=no, 1=weak, 2=pronounced): erosions, hyperkeratosis, fissures, agglutination, stenosis, atrophy). Possible sum score ranges from 0 (normal) to 12 (maximum symptoms present). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vulvovaginal symptom questionnaire (VSQ) | 21 binary questions (0=no, 1=yes) about symptoms, emotional impact, impact on quality of life, impact on sexual activity. Total possible sum score is 21. | At each visit through study completion, an average of 1 year | 
| Symptom strength score | Visual analog scale (0-10) of LS symptoms itching, burning, vulvar pain, dyspareunia. Total sum score ranges from 0 (no symptoms) to 40 (maximal symptoms). | At each visit through study completion, an average of 1 year |