Laser Therapy in Women With Lichenoid Disorders

NCT04697563 | Completed DMC

• 1 other identifier: Liser
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lichen Sclerosus Et Atrophicus; Lichen Planus

Outcome Measures

Primary Outcomes (1)

• subjective bother of lichenoid disorders (LD)

  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

  3 months

Secondary Outcomes (7)

• Treatment discomfort / pain

  3 months

• subjective symptoms of lichenoid disorders

  3 months

• Patient Global Impression of Improvement- PGI-I

  3 months

• Patient Global Impression of Severity- PGI-S

  3 months

• architectural changes

  3 months

Study Arms (2)

Laser

ACTIVE COMPARATOR

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.

Device: Laser

Placebo Laser

PLACEBO COMPARATOR

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.

Device: Placebolaser

Interventions

Laser DEVICE

real laser beam administered

Also known as: Fotona Smooth XS laser

Laser

Placebolaser DEVICE

no laser beam admitted

Also known as: Fotona Smooth XS laser placebo

Placebo Laser

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: only females can participate in this study because it is lead by gynecologists
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Obstetrics, Medical University Graz

Graz, 8045, Austria

Location

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus; Lichen Planus

Interventions

Lasers

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The person who performs the laser treatment is unaware of the treatment given The laser devices can be used as a placebo laser by blocking the laser beam with a plug
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double-blinded placebo- controlled clinical study

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: November 17, 2020
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)