Clinical trial NCT03525522: Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus
Official title: Efficacy of Nd:Yttrium Aluminum Garnet Laser Treatment of Lichen Sclerosus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lichen Sclerosus
Lichen Sclerosus Et Atrophicus
Keywords: Lichen sclerosus
laser
Nd:YAG
randomized controlled trial
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Juna d.o.o.
First posted: 2018-05-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients assigned randomly to two groups: laser-treatment group and topical-corticosteroid group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Change in Visual analog scale (VAS) score symptom evaluation from baseline to 1 month
timeFrame: Change from baseline to 1 month
measure: Change in Visual analog scale (VAS) score symptom evaluation from baseline to 6 months
timeFrame: Change from baseline to 6 months
measure: Comparative histological evaluation
timeFrame: baseline and 3 months
measure: patient satisfaction
timeFrame: 1 month
measure: patient satisfaction
timeFrame: 3 months
measure: patient satisfaction
timeFrame: 6 months
measure: evaluation of improvement from clinical photographs
timeFrame: 3 months
Other outcomes:
measure: tolerability of first laser treatment (pain and discomfort) on a 1-10 VAS scale
timeFrame: day 0 (first laser treatment)
measure: tolerability of second laser treatment (pain and discomfort) on a 1-10 VAS scale
timeFrame: day 14 (second laser treatment)
measure: tolerability of third laser treatment (pain and discomfort) on a 1-10 VAS scale
timeFrame: 1 month (third laser treatment)
Locations:
Study officials:
affiliation: UKC Ljubljana
name: Adolf Lukanović, PhD
role: PRINCIPAL_INVESTIGATOR
References: