Laser Treatment of Basal Cell Carcinoma

Study Overview
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Brief Summary
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Laser treatment of Basal cell carcinoma

Detailed Description
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The purpose of this pilot study is to examine the treatment of superficial basal cell carcinoma (BCC) with laser technology. The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC.

Official Title
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Laser Treatment of Basal Cell Carcinoma

Conditions
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Basal Cell Carcinoma

Intervention / Treatment
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* Device: 1064 nm long-pulse Nd:YAG laser
* Device: 1064 nm long-pulse Nd:YAG laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects 18 years of age or older Lesion is biopsy-proven superficial BCC <= 2.0 cm in largest diameter BCC is on trunk or extremities Seeks and is scheduled for treatment of BCC Willing to have photographs taken of the treatment area Ability to understand and the willingness to sign a written informed consent document Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions Exclusion Criteria: Subjects with a BCC lesion that requires excision. This would include relatively larger lesions (>2.0 cm in diameter), high risk lesions as defined by American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases. Pregnancy Subjects unable to follow-up for the full 12-months Subjects not willing to have biopsy taken from the treatment area Subjects with herpes simplex virus infection, impetigo or other disqualifying condition as determined by a dermatologist on the treatment area or effecting healing or outcome

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec | Device: 1064 nm long-pulse Nd:YAG laser<br>* BCC lesion will be treated with long-pulse 1064 laser<br>|
| Active Comparator: Slow<br>1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec | Device: 1064 nm long-pulse Nd:YAG laser<br>* BCC lesion will be treated with long-pulse 1064 laser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clearance of BCC | Histological confirmation of BCC clearance. Biopsy will be taken from the treatment site to confirm complete BCC clearance | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic outcome | Cosmetic outcome and any adverse effects of the laser treatment will be assessed | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superficial Basal Cell Carcinoma