Status:
COMPLETED
Laser Therapy in Women With Lichenoid Disorders
Lead Sponsor:
Medical University of Graz
Conditions:
Lichen Sclerosus Et Atrophicus
Lichen Planus
Eligibility:
FEMALE
18-99 years
Phase:
NA
Brief 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 therap...
Detailed Description
Background: Lichenoid Disorders (LD) include VLS (Vulvar lichen sclerosus) and LP (Lichen planus). VLS and LP are chronic skin diseases that usually affect the anogenital region. Both can cause vulvar...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04697563
Start Date
November 17 2020
End Date
June 13 2024
Last Update
May 13 2025
Active Locations (1)
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1
Department of Obstetrics, Medical University Graz
Graz, Austria, 8045