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The aim of this study is to show that the Nd:YAG laser could be a promising alternative treatment option in the management of low-risk basal cell carcinomas with similar high efficacy rates to surgery, and low recurrence rates evaluated over a time period of one year. Reflectance confocal microscopy, optical coherence tomography and clinical examination are used prior to confirm the clinical diagnosis of the basal cell carcinoma and for premargination of the tumor. The optical coherence tomography will also be used post treatment to confirm clearance of the basal cell carcinoma and to monitor treatment response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nd:YAG treatment arm | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cynosure Cynergy Nd:YAG Laser 1064nm | Device | The Nd:YAG Laser 1064nm is intended to be used as a treatment option in individuals suffering from low-risk basal cell carcinoma(s). |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficacy of Nd:YAG Laser 1064-nm for low risk basal cell carcinomas | Clearance rate of basal cell carcinomas after 1-3 Nd:YAG laser treatments evaluated by clinical inspectation, dermatosopy and optical coherence tomography. | 8 weeks after the treatment |
| Recurrence Rate after Nd:YAG Laser treatment | To assess the recurrence rate after a long-term follow-up of 6 and 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | To assess treatment tolerability of the Nd:YAG Laser 1064-nm (e.g. pain according to a Numerical rating scale, scarring, wound healing, secondary infection rate) | 6 and 12 months after treatment |
| Cosmetic outcome after laser treatment |
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Inclusion Criteria:
Patients with one or more basal cell carcinoma(s) on head, trunk or extremities
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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This will be assess according to an assessment scale including following parameters:
|
| 6 and 12 months after treatment |
| D018295 |
| Neoplasms, Basal Cell |