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

This study has been completed.
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00988455
First received: September 29, 2009
Last updated: October 1, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Basal Cell Carcinoma
 Radiation: photodynamic therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: January 2008
Study Completion Date: August 2009
Primary Completion Date: March 2009 (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
5-ALA cream 20% topical administration + photodynamic therapy (red light) 120 j/cm2
Other Name: PDT 1200L Waldman Medizintechnik, Villengen; 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 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.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988455

Sponsors and Collaborators
Shaheed 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
ClinicalTrials.gov Identifier: NCT00988455     History of Changes
Other Study ID Numbers: pdt bcc 2, zthr
Study First Received: September 29, 2009
Last Updated: October 1, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Shaheed 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 May 16, 2013