Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus

Overview

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.

Full Title of Study: “Efficacy of Nd:Yttrium Aluminum Garnet Laser Treatment of Lichen Sclerosus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 30, 2018

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.

Interventions

  • Device: Nd:YAG Laser
    • Three sessions of Nd:YAG treatment every two weeks.
  • Drug: Topical corticosteroid Diprosone
    • 3 months of topical corticosteroids Diprosone

Arms, Groups and Cohorts

  • Experimental: Nd:YAG Laser
    • Three sessions of Nd:YAG laser (1064 nm) treatment with Dynamis (Fotona, Slovenia)
  • Active Comparator: Topical Corticosteroid Diprosone
    • Topical corticosteroid betamethasone (Diprosone, Merck Sharp & Dohme, d.o.o.) for 3 months.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dr Adolf Lukanovič
  • Collaborator
    • Juna d.o.o.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dr Adolf Lukanovič, Medical Director of the Division of Gynaecology – University Medical Centre Ljubljana
  • Overall Official(s)
    • Adolf Lukanović, PhD, Principal Investigator, UKC Ljubljana

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