Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus

Study Overview
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Brief Summary
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With this trial the investigators look for the effect of Laser maintenance therapy in patients with vulvar lichen sclerosus compared to the maintenance standard treatment clobetasol propionate.

Detailed Description
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Vulvar Lichen sclerosus (VLS) is a chronic inflammatory cutaneous disorder, which can lead to scarring, impaired sexual function and malignancy. Gold standard treatment is topical corticosteroids (TCS) initially daily for 12 weeks. To avoid new flourishing of the disease a life-long maintenance treatment 2x/week is later recommended. Fractional CO2-Laser has shown a positive effect on vulvovaginal skin quality with improvement of urogenital atrophy and also lichen sclerosus. This randomised trial compares efficacy of laser treatment to TCS maintenance as well as the duration of the laser effect.

Official Title
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Monocentric, Prospective, Randomised, Single Blinded, Active-controlled Trial to Prove That the Treatment With Monalisa Glide is Equal to Topic Clobetasol Propionate Maintenance Therapy in Vulvar Lichen Sclerosus

Conditions
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Lichen Sclerosus

Intervention / Treatment
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* Device: Treatment with Monalisa Glide Laser
* Drug: Treatment with Clobetasol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre- or postmenopausal 12 weeks of continuous topical clobetasol treatment completed. Written informed consent German speaking (Study information and IC available only in German) Exclusion Criteria: Contraindication and limitations for the use of Mona Lisa Glide-Laser as described in the instructions for use Contraindication for the use of topic clobetasol History of vulva laser Immune-suppression Pregnancy or planned pregnancy, breast feeding. Clinically significant concomitant diseases states as severe renal failure, hepatic dysfunction, severe cardiovascular disease, cancer. History of vulvar or pelvic radiation therapy Uncertain vulvar findings, which require a biopsy. Acute vulvitis, especially recurrent genital herpes History of vaginal mesh implantation within 6 months preceding this study Known or suspected non-compliance, drug or alcohol abuse Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation Previous enrolment into the current investigation Enrolment of the PI, his/her family members, employees and other dependent persons

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: Monocentric, prospective, randomized, single-blinded, active-controlled
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser group<br>3 monthly fractional laser treatment according to the user manual (correct applicator, vulvar and vaginal preset). In between daily local skin care with a drug free product of patients' choice. | Device: Treatment with Monalisa Glide Laser<br>* 3 fractional laser treatment-sessions with Monalisa Glide<br>|
| Active Comparator: Clobetasol group<br>Maintenance treatment with vulvar TCS (clobetasol) application 2x/week. Instruction given at trial start and monthly check up for treatment control Daily local skin care with a drug free product of patients' choice. | Drug: Treatment with Clobetasol<br>* Application of Clobetasol twice per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lichen Score | The difference between the initial Lichen score and the score at 3 month after treatment start = 1 month after EOT | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lichen Score Follow up | Lichen score at 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms) | 15 months | 
| Vulva assessment Scale | Vulva assessment scale at 1, 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms) | 15 months | 
| German Pelvic floor questionnaire | Shortened Pelvic floor questionnaire at 1, 4, 8, 12 months after EOT | 15 months |