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

Primary Purpose

Basal Cell Carcinoma, Squamous Cell Carcinoma in Situ

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PDL Treatment
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring pulsed dye laser, PDL, basal cell carcinoma, squamous cell carcinoma, BCC, SCC, 594nM laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control

    PDL Setting 1

    PDL Setting 2

    Arm Description

    No treatment administered

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

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    November 22, 2010
    Last Updated
    August 14, 2019
    Sponsor
    University of California, San Diego
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01245972
    Brief Title
    Pilot Study of PDL to Treat BCC and SCCIS
    Acronym
    PDLNMSC
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, San Diego

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Basal Cell Carcinoma, Squamous Cell Carcinoma in Situ
    Keywords
    pulsed dye laser, PDL, basal cell carcinoma, squamous cell carcinoma, BCC, SCC, 594nM laser

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No treatment administered
    Arm Title
    PDL Setting 1
    Arm Type
    Experimental
    Arm Description
    PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes
    Arm Title
    PDL Setting 2
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Procedure
    Intervention Name(s)
    PDL Treatment
    Intervention Description
    Pulsed-dye laser (PDL) treatment at one of two settings.
    Primary Outcome Measure Information:
    Title
    Tumor Clearance
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    S. I. Brian Jiang, MD
    Organizational Affiliation
    UCSD Medical Center, Division of Dermatology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Pilot Study of PDL to Treat BCC and SCCIS

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