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 range
18 Years – 99 Years
Sex
FEMALE
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used laser therapy specifically for lichen sclerosus and lichen planus — how does laser treatment compare to the standard options I might already be considering, like topical steroids or other medications?
2Since this trial is completed and was measuring how much bother or discomfort lichenoid disorders cause patients, has the results data been published yet, and what did it show about whether laser therapy actually reduced symptoms?
3This study was listed as 'Phase NA,' which often means it's more of a feasibility or observational study rather than a large randomized controlled trial — does that affect how confident we can be in the safety and effectiveness of laser therapy based on this research?
4Laser therapy for conditions like lichen sclerosus or lichen planus isn't something I've heard much about — is this an approach that's available to me now outside of a trial setting, and would it be appropriate for my specific situation?
5Are there any known risks or side effects from using laser therapy in the vulvar or mucosal areas affected by these lichenoid disorders that I should weigh before considering this as a treatment path?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.