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Laser Therapy in Women With Lichenoid Disorders (Liser)

Primary Purpose

Lichen Sclerosus Et Atrophicus, Lichen Planus

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Laser
Placebolaser
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Sclerosus Et Atrophicus

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Obstetrics, Medical University GrazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Laser

Placebo Laser

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Treatment discomfort / pain
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)
subjective symptoms of lichenoid disorders
The Skindex questionnaire will be used to evaluate patients' subjective symptoms of lichenoid disorders
Patient Global Impression of Improvement- PGI-I
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.
Patient Global Impression of Severity- PGI-S
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.
architectural changes
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.
Histological analysis of LD
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.
Patient satisfaction with treatment/ inpatient management
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.

Full Information

First Posted
January 4, 2021
Last Updated
July 6, 2023
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT04697563
Brief Title
Laser Therapy in Women With Lichenoid Disorders
Acronym
Liser
Official Title
Laser Therapy in Women With Lichenoid Disorders: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Sclerosus Et Atrophicus, Lichen Planus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized double-blinded placebo- controlled clinical study
Masking
ParticipantInvestigator
Masking Description
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
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Laser
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Laser
Other Intervention Name(s)
Fotona Smooth XS laser
Intervention Description
real laser beam administered
Intervention Type
Device
Intervention Name(s)
Placebolaser
Other Intervention Name(s)
Fotona Smooth XS laser placebo
Intervention Description
no laser beam admitted
Primary Outcome Measure Information:
Title
subjective bother of lichenoid disorders (LD)
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Treatment discomfort / pain
Description
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)
Time Frame
3 months
Title
subjective symptoms of lichenoid disorders
Description
The Skindex questionnaire will be used to evaluate patients' subjective symptoms of lichenoid disorders
Time Frame
3 months
Title
Patient Global Impression of Improvement- PGI-I
Description
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.
Time Frame
3 months
Title
Patient Global Impression of Severity- PGI-S
Description
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.
Time Frame
3 months
Title
architectural changes
Description
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.
Time Frame
3 months
Title
Histological analysis of LD
Description
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.
Time Frame
3 months
Title
Patient satisfaction with treatment/ inpatient management
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
only females can participate in this study because it is lead by gynecologists
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Department of Obstetrics, Medical University Graz
City
Graz
ZIP/Postal Code
8045
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Ulrich, MD, PhD
Phone
+4331638581437
Email
daniela.ulrich@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Daniela Gold, M.D.
First Name & Middle Initial & Last Name & Degree
Karl Tamussino, MD
First Name & Middle Initial & Last Name & Degree
Gerda Trutnovsky, MD
First Name & Middle Initial & Last Name & Degree
Nadja Taumberger, MD
First Name & Middle Initial & Last Name & Degree
Anna Schütz, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Laser Therapy in Women With Lichenoid Disorders

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