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
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
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
NCT ID
NCT03525522
First Posted
April 5, 2018
Last Updated
May 14, 2018
Sponsor
Dr Adolf Lukanovič
Collaborators
Juna d.o.o.
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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Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus
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