Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus

Dr Adolf Lukanovič

Status: Unknown

Conditions: Lichen Sclerosus Et Atrophicus; Lichen Sclerosus

Treatments: Drug: Topical corticosteroid Diprosone; Device: Nd:YAG Laser

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03525522

Lichen_NdYAG

Details and patient eligibility

About

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 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Nd:YAG Laser

Experimental group

Description:

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

Treatment:

Device: Nd:YAG Laser

Topical Corticosteroid Diprosone

Active Comparator group

Description:

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

Treatment:

Drug: Topical corticosteroid Diprosone