Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00985829
First received: September 26, 2009
Last updated: November 18, 2009
Last verified: November 2009
  Purpose

The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.


Condition Intervention Phase
Basal Cell Carcinoma
Radiation: photodynamic therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • Clinical Response to Photodynamic Therapy [ Time Frame: immediately after termination of treatment course (with an average of 5 month after initiation of PDT) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Histologic Resolution of Lesion [ Time Frame: immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT) ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BCC, ALA-PDT
Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT
Radiation: photodynamic therapy
treatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly
Other Name: PDT 1200L Waldman Medizintechnik; Schwenningen, Germany

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985829

Sponsors and Collaborators
Shahid Beheshti Medical University
Investigators
Principal Investigator: Zohreh Tehranchi-nia, assist.prof. Skin Research Center
  More Information

No publications provided

Responsible Party: Zohreh Tehranchi-nia, assistant professor of dermatology Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT00985829     History of Changes
Other Study ID Numbers: pdt bcc1
Study First Received: September 26, 2009
Results First Received: September 30, 2009
Last Updated: November 18, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
basal cell carcinoma
photodynamic therapy
photo chemotherapy
basal cell epithelioma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on July 26, 2014