Clinical trial NCT04697563: Laser Therapy in Women With Lichenoid Disorders
Official title: Laser Therapy in Women With Lichenoid Disorders: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lichen Sclerosus Et Atrophicus
Lichen Planus
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blinded placebo- controlled clinical study
Primary purpose: TREATMENT

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 therapy at three months.

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 itching, burning and pain and can lead to urinary and sexual dysfunction. Current treatment options are unsatisfactory. Vulvovaginal laser therapy might be an effective treatment option.

Study aim: To study the effectiveness of non-ablative vulvovaginal laser therapy for women with lichenoid disorders.

Design: Randomized double-blinded placebo- controlled clinical study

Study Population: Women diagnosed with LD will be recruited from a specialized University outpatient clinic.

Study groups: Participants will be randomized (1:1). Intervention group: Laser therapy (2 treatments), plus ongoing therapy Control group: Sham laser therapy (2 treatments) plus ongoing therapy

Sample size Total 40 patients Primary study outcome: Visual analogue scale (VAS) composite score in regard to LD Secondary study outcomes: quality of life (QoL) (Skindex questionnaire); Treatment discomfort/ pain (VAS); Patient treatment satisfaction (Questionnaire to ask for treatment satifsaction: ZUF-8); Subjective improvement (Patient global impression of improvement- PGI-I), clinical LS score, histological appearance

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.

Primary outcomes:
measure: subjective bother of lichenoid disorders (LD)
timeFrame: 3 months
Secondary outcomes:
measure: Treatment discomfort / pain
timeFrame: 3 months
measure: subjective symptoms of lichenoid disorders
timeFrame: 3 months
measure: Patient Global Impression of Improvement- PGI-I
timeFrame: 3 months
measure: Patient Global Impression of Severity- PGI-S
timeFrame: 3 months
measure: architectural changes
timeFrame: 3 months
measure: Histological analysis of LD
timeFrame: 3 months
measure: Patient satisfaction with treatment/ inpatient management
timeFrame: 3 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Obstetrics, Medical University Graz
Study officials:
References: