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Lichen SclerosusNCT03525522

Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus

A study testing Nd:YAG Laser and Topical corticosteroid Diprosone in people with Lichen Sclerosus and Lichen Sclerosus Et Atrophicus, run by Dr Adolf Lukanovič.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluates the efficacy of Nd:Yttrium Aluminum Garnet Laser (Nd:YAG) Treatment of Lichen sclerosus in comparison with topical corticosteroid treatment. Half of participants will receive laser treatment and the other half corticosteroid treatment and the results will be followed for 6 months. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Nd:YAG Laser and Topical corticosteroid Diprosone
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
28 Jan 2016to 30 May 2018
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histologically confirmed Lichen sclerosus
  • voluntary signed informed consent

Who cannot join

  • pregnancy
  • use of photosensitizing medication
  • pathology other than Lichen
  • damage of tissues in the treatment area
  • other inflammation
  • refusal to sign informed consent

About this study

Official title: Efficacy of Nd:Yttrium Aluminum Garnet Laser Treatment of Lichen Sclerosus

This study evaluates the efficacy of Nd:Yttrium Aluminum Garnet Laser (Nd:YAG) Treatment of Lichen sclerosus in comparison with topical corticosteroid treatment. Half of participants will receive laser treatment and the other half corticosteroid treatment and the results will be followed for 6 months.

Read the detailed description

Lichen sclerosus (LS) is a chronic skin disease of unknown cause and very unpleasant symptoms which significantly influences the quality of life of the affected patients. Large majority of LS lesions is located in anogenital region where initial white flat papules usually develop into large, white patches of thin, itchy skin causing fusion of labia minora, narrowing of the introitus and burying of the clitoris. Most common symptoms are itching, pain, soreness, burning, dyspareunia and dysuria all strongly interfering with sexual function and patient's self image. Existing treatment options with systemic and topical medications (oral retinoids, topical steroids) have some drawbacks and recently the use of laser was proposed for treatment of LS. This study evaluates the safety and efficacy of Nd:Yttrium Aluminum Garnet Laser (Nd:YAG) Treatment of Lichen sclerosus in comparison with topical corticosteroid treatment. Half of participants will receive laser treatment and the other half corticosteroid treatment and the results will be followed for 6 months.

Being tested
Nd:YAG Laser, Topical corticosteroid Diprosone
Keywords
Lichen sclerosus, laser, Nd:YAG, randomized controlled trial
Medical subject headings
Lichen Sclerosus et Atrophicus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nd:YAG LaserDevice

    Also called Nd:YAG, neodymium, Dynamis

    Three sessions of Nd:YAG treatment every two weeks.

  • Topical corticosteroid DiprosoneDrug

    Also called topical corticosteroids betamethasone

    3 months of topical corticosteroids Diprosone

Study groups in NCT03525522
Study groupRoleWhat they receive
Nd:YAG LaserExperimentalThree sessions of Nd:YAG laser (1064 nm) treatment with Dynamis (Fotona, Slovenia)
Receives: Device: Nd:YAG Laser
Topical Corticosteroid DiprosoneActive comparatorTopical corticosteroid betamethasone (Diprosone, Merck Sharp \& Dohme, d.o.o.) for 3 months.
Receives: Drug: Topical corticosteroid Diprosone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months

    Patients will evaluate symptoms on a 0-10 VAS scale

    Measured: Change from baseline to 3 months

Secondary outcomes (7)

  1. Change in Visual analog scale (VAS) score symptom evaluation from baseline to 1 month

    Patients will evaluate symptoms on a 0-10 VAS scale

    Measured: Change from baseline to 1 month

  2. Change in Visual analog scale (VAS) score symptom evaluation from baseline to 6 months

    Patients will evaluate symptoms on a 0-10 VAS scale

    Measured: Change from baseline to 6 months

  3. Comparative histological evaluation

    biopsies taken at baseline and after treatment

    Measured: baseline and 3 months

  4. patient satisfaction

    Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.

    Measured: 1 month

  5. patient satisfaction

    Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.

    Measured: 3 months

  6. patient satisfaction

    Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.

    Measured: 6 months

  7. evaluation of improvement from clinical photographs

    by blinded evaluators on a 1-4 scale

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2018
  2. Study start28 Jan 2016
  3. Primary completion30 May 2018 (estimated)
  4. Study completion30 May 2018 (estimated)

Resources

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
Patients assigned randomly to two groups: laser-treatment group and topical-corticosteroid group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525522
Sponsor's protocol ID
Lichen_NdYAG
Status last verified
May 2018
First submitted
5 Apr 2018
Last updated
15 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nd:YAG Laser and Topical corticosteroid Diprosone in people with Lichen Sclerosus and Lichen Sclerosus Et Atrophicus, run by Dr Adolf Lukanovič.

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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Results are not available in the source record.

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?

Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months (time frame: Change from baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03525522.

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 15 May 2018.

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