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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Three sessions of Nd:YAG treatment every two weeks.
3 months of topical corticosteroids Diprosone
Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months
Patients will evaluate symptoms on a 0-10 VAS scale
Time frame: Change from baseline to 3 months
Change in Visual analog scale (VAS) score symptom evaluation from baseline to 1 month
Patients will evaluate symptoms on a 0-10 VAS scale
Time frame: 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
Time frame: Change from baseline to 6 months
Comparative histological evaluation
biopsies taken at baseline and after treatment
Time frame: baseline and 3 months
patient satisfaction
Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.
Time frame: 1 month
patient satisfaction
Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.
Time frame: 3 months
patient satisfaction
Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.
Time frame: 6 months
evaluation of improvement from clinical photographs
by blinded evaluators on a 1-4 scale
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Time frame: 3 months