Pilot Study of PDL to Treat BCC and SCCIS

Study Overview
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Brief Summary
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This is a research study to find out more about the use of the pulsed dye laser in the treatment of basal cell carcinoma and early stage squamous cell carcinoma that has not invaded deep into the skin. The purpose of this study is to determine whether the use of the pulsed dye laser (PDL) can completely clear or regress basal cell carcinoma or early stage squamous cell carcinoma. Pulsed dye laser is a type of laser that is commonly used to treat lesions on the skin that have a prominent blood vessel component. It has been used to treat broken blood vessels on the face, hemangiomas in children and adults, leg veins, port wine stains, and other lesions with a prominent vascular component.

Official Title
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A Pilot Study to Examine the Effectiveness of 595nM Pulsed Dye Lasers in the Treatment of Basal Cell Carcinoma and Squamous Cell Carcinoma in Situ

Conditions
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Basal Cell Carcinoma, Squamous Cell Carcinoma in Situ

Intervention / Treatment
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* Procedure: PDL Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring surgical excision (conventional or Mohs) for biopsy-proven basal cell carcinoma and biopsy-proven squamous cell carcinoma in situ that is clinically present at the pre-operative visit and measures greater than 0.4cm and less than 3cm in size. Lesions in the Trunk, Extremities, and Scalp Presence of clinically identifiable residual tumor. Patients, males and females, aged 18-90 years. Willing to participate. Able to give informed consent. Exclusion Criteria: Age younger than 18 years Location of lesion not in the Trunk, Extremities, and Scalp Fitzpatrick skin type V or VI. Prior history of known light sensitivity. Pregnancy Cognitive Impairment Prisoner

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No treatment administered | |
| Experimental: PDL Setting 1<br>PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes | Procedure: PDL Treatment<br>* Pulsed-dye laser (PDL) treatment at one of two settings.<br>|
| Experimental: PDL Setting 2<br>PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses | Procedure: PDL Treatment<br>* Pulsed-dye laser (PDL) treatment at one of two settings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Clearance | Review of the pathology report showing whether there was residual tumor or not. If there was no residual tumor in the pathology report from the confirmatory excision, the laser treatment was considered successful (tumor clearance). | 21 to 36 days after the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDL, pulsed dye laser, basal cell carcinoma, squamous cell carcinoma, BCC, SCC, 594nM laser