Basal Cell Carcinoma, Squamous Cell Carcinoma in Situ
Conditions
Keywords
pulsed dye laser, PDL, basal cell carcinoma, squamous cell carcinoma, BCC, SCC, 594nM laser
Brief summary
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.
Interventions
PROCEDUREPDL Treatment
Pulsed-dye laser (PDL) treatment at one of two settings.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Clearance | 21 to 36 days after the treatment | 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control No treatment administered | 7 |
| 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. | 8 |
| 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. | 8 |
| Total | 23 |
Baseline characteristics
| Characteristic | Control | PDL Setting 1 | PDL Setting 2 | Total |
|---|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 12 | 66 years STANDARD_DEVIATION 12 | 56 years STANDARD_DEVIATION 12 | 62 years STANDARD_DEVIATION 12 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 7 | 4 / 8 | 6 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 | 0 / 8 |
Outcome results
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).
Time frame: 21 to 36 days after the treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Tumor Clearance | 2 Participants |
| PDL Setting 1 | Tumor Clearance | 2 Participants |
| PDL Setting 2 | Tumor Clearance | 5 Participants |