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Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00985829
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : December 22, 2009
Last Update Posted : December 22, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Radiation: photodynamic therapy Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma
Study Start Date : January 2008
Primary Completion Date : July 2008
Study Completion Date : March 2009
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Clinical Response to Photodynamic Therapy [ Time Frame: immediately after termination of treatment course (with an average of 5 month after initiation of PDT) ]

Secondary Outcome Measures :
  1. Histologic Resolution of Lesion [ Time Frame: immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT) ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985829

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

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
First Posted: September 28, 2009    Key Record Dates
Results First Posted: December 22, 2009
Last Update Posted: December 22, 2009
Last Verified: November 2009

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

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