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Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

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

    Clinical Response to Photodynamic Therapy
    categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced

    Secondary Outcome Measures

    Histologic Resolution of Lesion
    disappearance of the lesion in histologic examination

    Full Information

    First Posted
    September 26, 2009
    Last Updated
    November 18, 2009
    Sponsor
    Shahid Beheshti University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00985829
    Brief Title
    Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma
    Official Title
    Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    March 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 pdt in treatment of bcc and factors that affect response rate.
    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 factors that may affect response rate. 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 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
    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; Schwenningen, Germany
    Intervention Description
    treatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly
    Primary Outcome Measure Information:
    Title
    Clinical Response to Photodynamic Therapy
    Description
    categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced
    Time Frame
    immediately after termination of treatment course (with an average of 5 month after initiation of PDT)
    Secondary Outcome Measure Information:
    Title
    Histologic Resolution of Lesion
    Description
    disappearance of the lesion in histologic examination
    Time Frame
    immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)
    Other Pre-specified Outcome Measures:
    Title
    Cosmetic Result
    Description
    excellent: no scarring, atrophy, or induration, slight or no redness or change in pigmentation compared to the adjacent skin; good: no scarring, atrophy, or induration, moderate redness or increase in pigmentation compared to the adjacent skin; moderate: slight to moderate scarring, atrophy, or induration; and poor: extensive scarring, atrophy, or induration
    Time Frame
    1 month after termination of treatment course (with an average of 6 months after initiation of PDT)
    Title
    Location of Lesion
    Time Frame
    baseline
    Title
    BCC Type
    Description
    superficial BCC (sBCC); pigmented BCC(pBCC);nodular BCC (nBCC)
    Time Frame
    baseline
    Title
    Past Medical History of Radiotherapy
    Description
    past medical history of radiotherapy to the site of tumor before its appearance(for another reason)
    Time Frame
    baseline

    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

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