Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus

Not Applicable

• Conditions: Lichen Sclerosus; Lichen Sclerosus Et Atrophicus
• Interventions: Drug: Topical corticosteroid Diprosone

• Registration Number: NCT03525522
• Lead Sponsor: Dr Adolf Lukanovič

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.

Study Timeline

• Study Start: 2016-01-28
• Study First Submitted: 2018-04-05
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-14
• Last Update Submitted: 2018-05-14
• Study First Posted: 2018-05-15
• Last Update Posted: 2018-05-15
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Corticosteroid Diprosone	Topical corticosteroid Diprosone	Topical corticosteroid betamethasone (Diprosone, Merck Sharp \& Dohme, d.o.o.) for 3 months.

Primary Outcome Measures

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

Secondary Outcome Measures

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