Laser Therapy in Women With Lichenoid Disorders (Liser)
Lichen Sclerosus Et Atrophicus, Lichen Planus
About this trial
This is an interventional treatment trial for Lichen Sclerosus Et Atrophicus
Eligibility Criteria
Inclusion criteria
- women age >18 years
- diagnosed with LD (VLS or LP histologically proven)
- Clinical LS score ≥ 4 based on the score of Günthert et al. [1]
- Normal Pap-smear within 24 months
- negative clinical and microscopic evaluation of vaginal fluid
- Negative test for STD (sexually transmitted diseases) pathogens (chlamydia, gonorrhea, genital mycoplasma and trichomonas) if symptomic including abdominal pain or abnormal vaginal fluid
- Good German language skills
- written informed consent
- preceding local corticoid therapy of at least 12 weeks according to the current guideline for LD
Exclusion criteria:
- women with contraindications for the use of laser on the skin
- pregnancy
- presence of vulvar pathology (other than lichen)
- any vulvar/ vaginal infection
- immunocompromised women
- swollen lymph nodes
- genital malignant disease
- allergy to topical anaesthesia
- connective tissue disease
- keloid formation
- Patients with a legal guardian
- Body Mass Index > 35 kg/m²
- History of transvaginal mesh implant (excluding sling or sacrocolpopexy mesh)
- Coagulopathy
- patients using anticoagulants
- patients with renal, hepatic or pulmonary-cardiovascular failure
- patients who have undergone any kind of organ transplantation in the last three years.
Sites / Locations
- Department of Obstetrics, Medical University GrazRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Laser
Placebo Laser
Before treatment the vulva will be carefully inspected to rule out signs of infection or recent trauma. A local anesthetic cream (Emla cream 5%) will be applied to the entire introitus vulvae and all areas intended for local laser treatment. Before laser treatment another cotton swab test will be performed to ensure sufficient local anesthesia. Vulvovaginal laser therapies will be performed with the non-ablative 2940 nm Er:YAG laser (Smooth XS, Fotona, Slovenia) in the Renova mode according to the manufacturer's guidelines and recommendations. The spot size (diameter of the laser beam) is 7 mm, with a pulse at a frequency of 1.6 Hz, and a fluence (laser energy delivered per unit area) of 5.0 to 10.0 J/cm2. The vulva will be treated using 1-3 repetitions.
Clinical examination and preparations will be identical to the intervention group. Sham laser treatments will be performed with the same laser and the same device. However, a specially designed placebo probe, which blocks the emission of radiation, will be used. Women will therefore receive no therapeutic laser treatment. Before treatment, a study assistant, who is aware of the study allocation, will prepare the laser with the placebo probe, which looks identically to the "normal" probe. The treating physician will not be aware of the study allocation and the type of probe in use.