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Completed

NCT Number: NCT04697563

Laser Therapy in Women With Lichenoid Disorders

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.

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Key information

Conditions

Lichen Sclerosus Et Atrophicus Lichen Planus Lichenoid Eruptions Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics, Medical University Graz

Graz, 8045, Austria

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laser

Device

real laser beam administered

Other names: Fotona Smooth XS laser

Placebolaser

Device

no laser beam admitted

Other names: Fotona Smooth XS laser placebo

Primary outcomes

  1. subjective bother of lichenoid disorders (LD)

    Time frame: 3 months

    A visual analogue scale (VAS) is used for assessment for the subjective bother of LD symptoms. Patients are asked to indicate the degree of each of the three following LD symptoms on a scale ranging from 0 (no symptoms) to 10 (worst possible symptoms):

    genital symptoms of itching, burning and vaginal pain resulting in a composite VAS score

Secondary outcomes

  1. Treatment discomfort / pain

    Time frame: 3 months

    patients are asked to indicate the degree of discomfort or pain during laser therapy on a visual analogue scale (VAS) ranging from 0 (no discomfort/pain) to 10 (worst possible discomfort/pain)

  2. subjective symptoms of lichenoid disorders

    Time frame: 3 months

    The Skindex questionnaire will be used to evaluate patients' subjective symptoms of lichenoid disorders

  3. Patient Global Impression of Improvement- PGI-I

    Time frame: 3 months

    The PGI-I scales are robust and valid instruments to assess disease severity, bother and improvement after treatment in women and will be used to determine the Patient Global Impression of Improvement. The PGI-I consists of a 7-likert-scale with 7 being the worst bother.

  4. Patient Global Impression of Severity- PGI-S

    Time frame: 3 months

    The Patient Global Impression of Severity (PGI-S) is a global index that may be used to rate the severity of a specific condition (a single-state scale). The PGI scales are robust and valid instruments to assess disease severity, bother and improvement after treatment and will be used to determine the Patient Global Impression of Severity. The PGI scales are robust and valid instruments to assess disease severity, bother and improvement after treatment. The patient can choose from 4 answers including none, mild, moderate and severe.

  5. architectural changes

    Time frame: 3 months

    The vulva will be inspected and structural changes due to LD will be recorded. The score is based on the publication from Günthert et al. The score records signs of erosions, hyperkeratosis, rhagades, synechia, stenosis, and atrophy of the vulva. The questionnaires is based on a 29-item version; the higher the score the more pronounced are the clinical signs.

  6. Histological analysis of LD

    Time frame: 3 months

    Lichenoid disorders show epidermic atrophy, sclerosis and a lymphocytic based dermal inflammation. Hyperkeratosis and dermal inflammation will be evaluated both from the histological probe before and after treatment. Each item will be scored from 1-3, mild, moderate and severe. A higher score indicates more severe expression of LD.

  7. Patient satisfaction with treatment/ inpatient management

    Time frame: 3 months

    Patient satisfaction will be evaluated with the "Fragebogen zur Patientenzufriedenheit - ZUF8". The German version of the original "Client Satisfaction Questionnaire-CSQ8", is a validated tool for measuring global patient satisfaction at the end of inpatient treatment. he Zuf-8 is an 8-items questionnaire to assess satisfaction in patients undergoing inpatient treatment. At 3 months treatment satisfaction will be assessed using an adopted version of the questionnaire. The lower the score the higher is the patient satiscation.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Laser Therapy in Women With Lichenoid Disorders: A Randomized Controlled Trial

Acronym: Liser

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2021
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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