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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No treatment administered | |
| PDL Setting 1 | Experimental | PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes |
|
| PDL Setting 2 | Experimental | PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDL Treatment | Procedure | Pulsed-dye laser (PDL) treatment at one of two settings. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| S. I. Brian Jiang, MD | UCSD Medical Center, Division of Dermatology | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | No treatment administered |
| FG001 | PDL Setting 1 | PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings. |
| FG002 | PDL Setting 2 | PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | No treatment administered |
| BG001 | PDL Setting 1 | PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | 21 to 36 days after the treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | No treatment administered | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| S. Brian Jiang | ucsdmed | 8586571663 | s2jiang@ucsd.edu |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D000081483 | Squamous Intraepithelial Lesions |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| BG002 | PDL Setting 2 | PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG002 |
| PDL Setting 2 |
PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings. |
|
|
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | PDL Setting 1 | PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG002 | PDL Setting 2 | PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings. | 0 | 8 | 0 | 8 | 6 | 8 |
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| D018295 |
| Neoplasms, Basal Cell |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018307 | Neoplasms, Squamous Cell |
| Male |
|