Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-28

Study Completion Date

2018-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lichen Sclerosus Lichen Sclerosus Et Atrophicus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients assigned randomly to two groups: laser-treatment group and topical-corticosteroid group.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Hystology and photographic assessment performed by independant investigators unaware of the assignement.

Study Groups

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Nd:YAG Laser

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

Group Type EXPERIMENTAL

Nd:YAG Laser

Intervention Type DEVICE

Three sessions of Nd:YAG treatment every two weeks.

Topical Corticosteroid Diprosone

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

Group Type ACTIVE_COMPARATOR

Topical corticosteroid Diprosone

Intervention Type DRUG

3 months of topical corticosteroids Diprosone

Interventions

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Nd:YAG Laser

Three sessions of Nd:YAG treatment every two weeks.

Intervention Type DEVICE

Topical corticosteroid Diprosone

3 months of topical corticosteroids Diprosone

Intervention Type DRUG

Other Intervention Names

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Nd:YAG neodymium Dynamis topical corticosteroids betamethasone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No