Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus

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.

Study Overview

• Status: Unknown
• Conditions: Lichen Sclerosus; Lichen Sclerosus Et Atrophicus
• Intervention / Treatment: Device: Nd:YAG Laser; Drug: Topical corticosteroid Diprosone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nd:YAG Laser; Three sessions of Nd:YAG laser (1064 nm) treatment with Dynamis (Fotona, Slovenia)	Device: Nd:YAG Laser; Three sessions of Nd:YAG treatment every two weeks.; Other Names: Nd:YAG; neodymium; Dynamis
Active Comparator: Topical Corticosteroid Diprosone; Topical corticosteroid betamethasone (Diprosone, Merck Sharp & Dohme, d.o.o.) for 3 months.	Drug: Topical corticosteroid Diprosone; 3 months of topical corticosteroids Diprosone; Other Names: topical corticosteroids betamethasone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
tolerability of first laser treatment (pain and discomfort) on a 1-10 VAS scale	rated by patients in the laser group on a 1-10 VAS scale	day 0 (first laser treatment)
tolerability of second laser treatment (pain and discomfort) on a 1-10 VAS scale	rated by patients in the laser group on a 1-10 VAS scale	day 14 (second laser treatment)
tolerability of third laser treatment (pain and discomfort) on a 1-10 VAS scale	rated by patients in the laser group on a 1-10 VAS scale	1 month (third laser treatment)

Collaborators and Investigators

• Sponsor: Dr Adolf Lukanovič
• Collaborators: Juna d.o.o.
• Investigators: Principal Investigator: Adolf Lukanović, PhD, UKC Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2016
• Primary Completion (Anticipated): May 30, 2018
• Study Completion (Anticipated): May 30, 2018

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: randomized controlled trial; laser; Nd:YAG; Lichen sclerosus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Sclerosus et Atrophicus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone-17,21-dipropionate
• Other Study ID Numbers: Lichen_NdYAG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No