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Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus

Primary Purpose

Lichen Sclerosus, Lichen Sclerosus Et Atrophicus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nd:YAG Laser
Topical corticosteroid Diprosone
Sponsored by
Dr Adolf Lukanovič
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Sclerosus focused on measuring Lichen sclerosus, laser, Nd:YAG, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • histologically confirmed Lichen sclerosus
  • voluntary signed informed consent

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Nd:YAG Laser

    Topical Corticosteroid Diprosone

    Arm Description

    Three sessions of Nd:YAG laser (1064 nm) treatment with Dynamis (Fotona, Slovenia)

    Topical corticosteroid betamethasone (Diprosone, Merck Sharp & Dohme, d.o.o.) for 3 months.

    Outcomes

    Primary Outcome Measures

    Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months
    Patients will evaluate symptoms on a 0-10 VAS scale

    Secondary Outcome Measures

    Change in Visual analog scale (VAS) score symptom evaluation from baseline to 1 month
    Patients will evaluate symptoms on a 0-10 VAS scale
    Change in Visual analog scale (VAS) score symptom evaluation from baseline to 6 months
    Patients will evaluate symptoms on a 0-10 VAS scale
    Comparative histological evaluation
    biopsies taken at baseline and after treatment
    patient satisfaction
    Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.
    patient satisfaction
    Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.
    patient satisfaction
    Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.
    evaluation of improvement from clinical photographs
    by blinded evaluators on a 1-4 scale

    Full Information

    First Posted
    April 5, 2018
    Last Updated
    May 14, 2018
    Sponsor
    Dr Adolf Lukanovič
    Collaborators
    Juna d.o.o.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03525522
    Brief Title
    Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus
    Official Title
    Efficacy of Nd:Yttrium Aluminum Garnet Laser Treatment of Lichen Sclerosus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 28, 2016 (Actual)
    Primary Completion Date
    May 30, 2018 (Anticipated)
    Study Completion Date
    May 30, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr Adolf Lukanovič
    Collaborators
    Juna d.o.o.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lichen Sclerosus, Lichen Sclerosus Et Atrophicus
    Keywords
    Lichen sclerosus, laser, Nd:YAG, randomized controlled trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients assigned randomly to two groups: laser-treatment group and topical-corticosteroid group.
    Masking
    Outcomes Assessor
    Masking Description
    Hystology and photographic assessment performed by independant investigators unaware of the assignement.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nd:YAG Laser
    Arm Type
    Experimental
    Arm Description
    Three sessions of Nd:YAG laser (1064 nm) treatment with Dynamis (Fotona, Slovenia)
    Arm Title
    Topical Corticosteroid Diprosone
    Arm Type
    Active Comparator
    Arm Description
    Topical corticosteroid betamethasone (Diprosone, Merck Sharp & Dohme, d.o.o.) for 3 months.
    Intervention Type
    Device
    Intervention Name(s)
    Nd:YAG Laser
    Other Intervention Name(s)
    Nd:YAG, neodymium, Dynamis
    Intervention Description
    Three sessions of Nd:YAG treatment every two weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Topical corticosteroid Diprosone
    Other Intervention Name(s)
    topical corticosteroids betamethasone
    Intervention Description
    3 months of topical corticosteroids Diprosone
    Primary Outcome Measure Information:
    Title
    Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months
    Description
    Patients will evaluate symptoms on a 0-10 VAS scale
    Time Frame
    Change from baseline to 3 months
    Secondary Outcome Measure Information:
    Title
    Change in Visual analog scale (VAS) score symptom evaluation from baseline to 1 month
    Description
    Patients will evaluate symptoms on a 0-10 VAS scale
    Time Frame
    Change from baseline to 1 month
    Title
    Change in Visual analog scale (VAS) score symptom evaluation from baseline to 6 months
    Description
    Patients will evaluate symptoms on a 0-10 VAS scale
    Time Frame
    Change from baseline to 6 months
    Title
    Comparative histological evaluation
    Description
    biopsies taken at baseline and after treatment
    Time Frame
    baseline and 3 months
    Title
    patient satisfaction
    Description
    Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.
    Time Frame
    1 month
    Title
    patient satisfaction
    Description
    Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.
    Time Frame
    3 months
    Title
    patient satisfaction
    Description
    Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.
    Time Frame
    6 months
    Title
    evaluation of improvement from clinical photographs
    Description
    by blinded evaluators on a 1-4 scale
    Time Frame
    3 months
    Other Pre-specified Outcome Measures:
    Title
    tolerability of first laser treatment (pain and discomfort) on a 1-10 VAS scale
    Description
    rated by patients in the laser group on a 1-10 VAS scale
    Time Frame
    day 0 (first laser treatment)
    Title
    tolerability of second laser treatment (pain and discomfort) on a 1-10 VAS scale
    Description
    rated by patients in the laser group on a 1-10 VAS scale
    Time Frame
    day 14 (second laser treatment)
    Title
    tolerability of third laser treatment (pain and discomfort) on a 1-10 VAS scale
    Description
    rated by patients in the laser group on a 1-10 VAS scale
    Time Frame
    1 month (third laser treatment)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: histologically confirmed Lichen sclerosus voluntary signed informed consent Exclusion Criteria: pregnancy use of photosensitizing medication pathology other than Lichen damage of tissues in the treatment area other inflammation refusal to sign informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adolf Lukanović, PhD
    Organizational Affiliation
    UKC Ljubljana
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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