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Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up

Primary Purpose

Basal Cell Carcinoma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
photodynamic therapy
Sponsored by
Shahid Beheshti University of Medical Sciences
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, photodynamic therapy, photo chemotherapy, basal cell epithelioma

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically proven BCCs

Exclusion Criteria:

  • Rodent ulcer
  • Morphea type
  • ANA +
  • History of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month
  • Pregnancy
  • Breast feeding
  • Age< 18
  • History of another therapeutic intervention for bcc during last 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    BCC, ALA-PDT

    Arm Description

    Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT

    Outcomes

    Primary Outcome Measures

    response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination)

    Secondary Outcome Measures

    recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up

    Full Information

    First Posted
    September 29, 2009
    Last Updated
    October 1, 2009
    Sponsor
    Shahid Beheshti University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00988455
    Brief Title
    Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Shahid Beheshti University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy of photodynamic therapy (PDT)in treatment of Basal cell carcinoma (BCC) and recurrence rate after 6 months.
    Detailed Description
    Background and Aim: Basal cell carcinoma (BCC) is the most common skin cancer .Photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. This study was designed with the aim of the evaluation of efficacy of PDT in treatment of BCC and recurrence rate after 6 months . Materials and Methods: This was a clinical trial which was done on 28 BCCs. Patients were treated with ALA-PDT monthly for 1-6 sessions and evaluated for clinical response,cosmetic results,recurrence rate and probable side effects.

    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, photodynamic therapy, photo chemotherapy, basal cell epithelioma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BCC, ALA-PDT
    Arm Type
    Experimental
    Arm Description
    Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT
    Intervention Type
    Radiation
    Intervention Name(s)
    photodynamic therapy
    Other Intervention Name(s)
    PDT 1200L Waldman Medizintechnik, Villengen; Schwenningen, Germany
    Intervention Description
    5-ALA cream 20% topical administration + photodynamic therapy (red light) 120 j/cm2
    Primary Outcome Measure Information:
    Title
    response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically proven BCCs Exclusion Criteria: Rodent ulcer Morphea type ANA + History of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month Pregnancy Breast feeding Age< 18 History of another therapeutic intervention for bcc during last 6 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    zohreh Tehranchi-nia, assist.prof.
    Organizational Affiliation
    skin research center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up

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