Pilot Study of PDL to Treat BCC and SCCIS (PDLNMSC)

University of California San Diego

Status: Completed

Conditions: Squamous Cell Carcinoma in Situ; Basal Cell Carcinoma

Treatments: Procedure: PDL Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01245972

HRPP-101001

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 3 patient groups

Control

No Intervention group

Description:

No treatment administered

PDL Setting 1

Experimental group

Description:

PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes

Treatment:

Procedure: PDL Treatment

PDL Setting 2

Experimental group

Description:

PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses

Treatment:

Procedure: PDL Treatment