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| Name | Class |
|---|---|
| Juna d.o.o. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nd:YAG Laser | Experimental | Three sessions of Nd:YAG laser (1064 nm) treatment with Dynamis (Fotona, Slovenia) |
|
| Topical Corticosteroid Diprosone | Active Comparator | Topical corticosteroid betamethasone (Diprosone, Merck Sharp & Dohme, d.o.o.) for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nd:YAG Laser | Device | Three sessions of Nd:YAG treatment every two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months | Patients will evaluate symptoms on a 0-10 VAS scale | Change from baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual analog scale (VAS) score symptom evaluation from baseline to 1 month | Patients will evaluate symptoms on a 0-10 VAS scale | Change from baseline to 1 month |
| Change in Visual analog scale (VAS) score symptom evaluation from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| tolerability of first laser treatment (pain and discomfort) on a 1-10 VAS scale | rated by patients in the laser group on a 1-10 VAS scale | day 0 (first laser treatment) |
| tolerability of second laser treatment (pain and discomfort) on a 1-10 VAS scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adolf Lukanović, PhD | UKC Ljubljana | Principal Investigator |
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| ID | Term |
|---|---|
| D018459 | Lichen Sclerosus et Atrophicus |
| ID | Term |
|---|---|
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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Patients assigned randomly to two groups: laser-treatment group and topical-corticosteroid group.
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Hystology and photographic assessment performed by independant investigators unaware of the assignement.
| Topical corticosteroid Diprosone | Drug | 3 months of topical corticosteroids Diprosone |
|
|
Patients will evaluate symptoms on a 0-10 VAS scale |
| Change from baseline to 6 months |
| Comparative histological evaluation | biopsies taken at baseline and after treatment | baseline and 3 months |
| patient satisfaction | Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale. | 1 month |
| patient satisfaction | Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale. | 3 months |
| patient satisfaction | Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale. | 6 months |
| evaluation of improvement from clinical photographs | by blinded evaluators on a 1-4 scale | 3 months |
rated by patients in the laser group on a 1-10 VAS scale
| day 14 (second laser treatment) |
| tolerability of third laser treatment (pain and discomfort) on a 1-10 VAS scale | rated by patients in the laser group on a 1-10 VAS scale | 1 month (third laser treatment) |