Laser Therapy in Women With Lichenoid Disorders

NCT ID: NCT04697563

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-17
• Study Completion Date: 2024-06-13

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

Conditions

Lichen Sclerosus Et Atrophicus; Lichen Planus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Laser

Intervention Type: DEVICE

real laser beam administered

Placebo Laser

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.

Group Type: PLACEBO_COMPARATOR

Placebolaser

Intervention Type: DEVICE

no laser beam admitted

Interventions

Laser

real laser beam administered

Intervention Type: DEVICE

Placebolaser

no laser beam admitted

Intervention Type: DEVICE

Other Intervention Names

Fotona Smooth XS laser; Fotona Smooth XS laser placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Obstetrics, Medical University Graz

Graz, , Austria

Countries

Austria

Other Identifiers

Liser

Identifier Type: -

Identifier Source: org_study_id