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

August 14, 2019 updated by: Dr. Shang I. Brian Jiang, University of California, San Diego

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No treatment administered
Experimental: 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
Procedure: PDL Treatment
Pulsed-dye laser (PDL) treatment at one of two settings.
Experimental: 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
Procedure: PDL Treatment
Pulsed-dye laser (PDL) treatment at one of two settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Clearance
Time Frame: 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).
21 to 36 days after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: S. I. Brian Jiang, MD, UCSD Medical Center, Division of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimate)

November 23, 2010

Study Record Updates

Last Update Posted (Actual)

September 16, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRPP-101001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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