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Short Term Effects of Photodynamic Therapy in Basal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01015898
First received: November 17, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 17, 2009
November 17, 2009
January 2008
July 2008   (final data collection date for primary outcome measure)
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Not Provided
No Changes Posted
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Short Term Effects of Photodynamic Therapy in Basal Cell Carcinoma
Short Term Effects of Photodynamic Therapy in Basal Cell Carcinoma

The purpose of this study is to evaluate the efficacy of photodynamic therapy in treatment of Basal cell carcinoma (BCC) and factors that affect response rate.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Basal Cell Carcinoma
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, Villengen; Schwenningen, Germany
Experimental: BCC, ALA-PDT
Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT
Intervention: Radiation: photodynamic therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01015898
pdt1
Yes
Zohreh Tehranchi-nia, assistant professor of dermatology Shaheed Beheshti Medical University
Shahid Beheshti Medical University
Not Provided
Principal Investigator: Zohreh Tehranchi-nia, assist.prof. Skin Research Center
Shahid Beheshti Medical University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP