Laser Therapy in Women With Lichenoid Disorders (NCT04697563) | Clinical Trial Compass
CompletedNot Applicable
Laser Therapy in Women With Lichenoid Disorders
Austria40 participantsStarted 2020-11-17
Plain-language summary
Primary aim of the trial is to compare improvement of lichen symptoms according to a composite VAS scale (burning, itching and pain) between women with vulvovaginal laser therapy vs. sham laser therapy at three months.
Who can participate
Age range18 Years – 99 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.