Lichen Sclerosus Et AtrophicusLiserNCT04697563
Laser Therapy in Women With Lichenoid Disorders
A study testing Laser in people with Lichen Sclerosus Et Atrophicus and Lichen Planus, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lichen Sclerosus Et Atrophicus, Lichen Planus
- What is being tested?
- Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 17 Nov 2020to 13 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Good German language skills
- written informed consent
- preceding local corticoid therapy of at least 12 weeks according to the current guideline for LD
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Therapy in Women With Lichenoid Disorders: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Laser, Placebolaser
- Medical subject headings
- Lichen Sclerosus et Atrophicus, Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserDevice
Also called Fotona Smooth XS laser
real laser beam administered
PlacebolaserDevice
Also called Fotona Smooth XS laser placebo
no laser beam admitted
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebolaser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (7)
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)
Measured: 3 months
subjective symptoms of lichenoid disorders
The Skindex questionnaire will be used to evaluate patients' subjective symptoms of lichenoid disorders
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start17 Nov 2020
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Sclerosus Et AtrophicusStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blinded placebo- controlled clinical study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697563
- Sponsor's protocol ID
- Liser
- Acronym
- Liser
- Status last verified
- May 2025
- First submitted
- 4 Jan 2021
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Therapy in Women With Lichenoid Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04697563
- Acronym / sponsor ID
- Liser / Liser
- Conditions
- Lichen Sclerosus Et Atrophicus, Lichen Planus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized double-blinded placebo- controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Laser | Active comparator | Device: LaserBefore 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. |
| Placebo Laser | Placebo comparator | Device: PlacebolaserClinical 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaserAlso: Fotona Smooth XS laserreal laser beam administered | Device | Laser |
| PlacebolaserAlso: Fotona Smooth XS laser placebono laser beam admitted | Device | Placebo Laser |
Primary outcome
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
7 secondary outcomes
Treatment discomfort / pain
Time frame: 3 months
subjective symptoms of lichenoid disorders
Time frame: 3 months
Patient Global Impression of Improvement- PGI-I
Time frame: 3 months
Patient Global Impression of Severity- PGI-S
Time frame: 3 months
architectural changes
Time frame: 3 months
Histological analysis of LD
Time frame: 3 months
Patient satisfaction with treatment/ inpatient management
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser in people with Lichen Sclerosus Et Atrophicus and Lichen Planus, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective bother of lichenoid disorders (LD) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.