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Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

Primary Purpose

Basal Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser treatment
SHAM-Treatment
Sponsored by
Hautklinik Darmstadt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring basal cell carcinoma, laser surgery, pulsed dye laser, randomized controlled trial

Eligibility Criteria

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

Inclusion Criteria:

  • histologically confirmed unpigmented sBCC on the trunk and extremities
  • maximal tumour diameter 30 mm

Exclusion Criteria:

  • Fitzpatrick skin type >III
  • pregnancy
  • previous BCC treatment within 4 weeks
  • coagulation disorders
  • photo sensitizing medication
  • any indication of poor compliance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Laser Treatment

    SHAM Treatment

    Arm Description

    Pulsed dye laser 595nm

    using the pulsed dye laser (PDL) laser without releasing a pulse

    Outcomes

    Primary Outcome Measures

    complete response

    Secondary Outcome Measures

    patients satisfaction
    questionnaire
    side effects
    questionnaire
    reduction of tumor diameter and tumor thickness

    Full Information

    First Posted
    April 13, 2014
    Last Updated
    April 27, 2014
    Sponsor
    Hautklinik Darmstadt
    Collaborators
    University Medicine Greifswald
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02125669
    Brief Title
    Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas
    Official Title
    The Role of the 595 nm Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas at Low Risk Anatomical Sites: Outcome of a Double Blind Randomized Placebo Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hautklinik Darmstadt
    Collaborators
    University Medicine Greifswald

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking due to inconsistent design of available studies. The purpose of this study is to evaluate the PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk anatomical sites in an evidence based study setting.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Basal Cell Carcinoma
    Keywords
    basal cell carcinoma, laser surgery, pulsed dye laser, randomized controlled trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Laser Treatment
    Arm Type
    Active Comparator
    Arm Description
    Pulsed dye laser 595nm
    Arm Title
    SHAM Treatment
    Arm Type
    Sham Comparator
    Arm Description
    using the pulsed dye laser (PDL) laser without releasing a pulse
    Intervention Type
    Procedure
    Intervention Name(s)
    Laser treatment
    Intervention Description
    Pulsed dye laser 595nm
    Intervention Type
    Device
    Intervention Name(s)
    SHAM-Treatment
    Intervention Description
    using the pulsed dye laser (PDL) laser without releasing a pulse
    Primary Outcome Measure Information:
    Title
    complete response
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    patients satisfaction
    Description
    questionnaire
    Time Frame
    9 months
    Title
    side effects
    Description
    questionnaire
    Time Frame
    9 months
    Title
    reduction of tumor diameter and tumor thickness
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: histologically confirmed unpigmented sBCC on the trunk and extremities maximal tumour diameter 30 mm Exclusion Criteria: Fitzpatrick skin type >III pregnancy previous BCC treatment within 4 weeks coagulation disorders photo sensitizing medication any indication of poor compliance
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maurizio Podda, Dr.
    Organizational Affiliation
    Hautklinik Darmstadt
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Syrus Karsai, Dr.
    Organizational Affiliation
    Hautklinik Darmstadt
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Heiko Friedl
    Organizational Affiliation
    Hautklinik Darmstadt
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

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