New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management

Study Overview
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Brief Summary
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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.

Official Title
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New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma

Conditions
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Basal Cell Carcinoma

Intervention / Treatment
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* Device: Cynosure Cynergy Nd:YAG Laser 1064nm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with one or more basal cell carcinoma(s) on head, trunk or extremities Diagnosed clinically, with a dermatoscope and through noninvasive imaging methods such as reflectance confocal microscopy and optical coherence tomography H zone <6mm, M zone <10mm, L zone <20mm Tumor thickness <2mm Clearly visible margins Exclusion Criteria: Pregnancy <18 years of age Current or history of immunosuppression Prior-treatment of the basal cell carcinoma/ recurrent basal cell carcinomas History of radiation in the area of basal cell carcinoma appearance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nd:YAG treatment arm<br> | Device: Cynosure Cynergy Nd:YAG Laser 1064nm<br>* The Nd:YAG Laser 1064nm is intended to be used as a treatment option in individuals suffering from low-risk basal cell carcinoma(s).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | This will be assess according to an assessment scale including following parameters: Pigmentation: hyperpigmentation, hypopigmentation, normal Vascularity: pink, red, purple, normal Pliability: firm, contracture, supple, yielding, ropes, normal Scarring: yes, no Overall opinion: Rating on a scale from 1-5 (school note system) Separate evaluation of observer and patient. | 6 and 12 months after treatment |