Pilot Study of PDL to Treat BCC and SCCIS

Not Applicable

Completed

• Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma in Situ
• Interventions: Procedure: PDL Treatment

• Registration Number: NCT01245972
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2019-07-03
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-14
• Last Update Submitted: 2019-08-14
• Results First Posted: 2019-09-16
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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).