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

N/AActive Not RecruitingNCT03926299

Prof. Dr. Volker Viereck66 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Skin Disease Vulvar Lichen Sclerosus

Interventions

FotonaSmooth SP® Spectro laser deviceDEVICE

dual laser treatment with thermal Nd:YAG and ablative Er:YAG (Fotona medical device), 4 laser sessions 4-8 weeks apart.

Clobetasol propionate 0.05% ointmentDRUG

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)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cantonal Hospital Frauenfeld

Frauenfeld, Thurgau, Switzerland

Outcomes

Primary Outcomes

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).

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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).

Time frame: At each visit through study completion, an average of 1 year

Data from ClinicalTrials.gov

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