Lichen Sclerosus, Lichen Sclerosus Et Atrophicus
Conditions
Keywords
Lichen sclerosus, laser, Nd:YAG, randomized controlled trial
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.
Interventions
DEVICENd:YAG Laser
Three sessions of Nd:YAG treatment every two weeks.
DRUGTopical corticosteroid Diprosone
3 months of topical corticosteroids Diprosone
Sponsors
Juna d.o.o.
Dr Adolf Lukanovič
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Hystology and photographic assessment performed by independant investigators unaware of the assignement.
Intervention model description
Patients assigned randomly to two groups: laser-treatment group and topical-corticosteroid group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Comparative histological evaluation | baseline and 3 months | biopsies taken at baseline and after treatment |
| 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 |
| evaluation of improvement from clinical photographs | 3 months | by blinded evaluators on a 1-4 scale |
| patient satisfaction | 1 month | Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale. |
Other
| Measure | Time frame | Description |
|---|---|---|
| tolerability of third laser treatment (pain and discomfort) on a 1-10 VAS scale | 1 month (third laser treatment) | rated by patients in the laser group on a 1-10 VAS scale |
| tolerability of second laser treatment (pain and discomfort) on a 1-10 VAS scale | day 14 (second laser treatment) | rated by patients in the laser group on a 1-10 VAS scale |
| tolerability of first laser treatment (pain and discomfort) on a 1-10 VAS scale | day 0 (first laser treatment) | rated by patients in the laser group on a 1-10 VAS scale |
Outcome results
None listed