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

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

September 29, 2009
October 1, 2009
January 2008
March 2009   (final data collection date for primary outcome measure)
response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00988455 on ClinicalTrials.gov Archive Site
recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up
Not Provided

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Basal Cell Carcinoma
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
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
August 2009
March 2009   (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
 
NCT00988455
pdt bcc 2, zthr
Yes
Zohreh Tehranchi-nia, assistant professor of dermatology
Shahid Beheshti Medical University
Not Provided
Principal Investigator: zohreh Tehranchi-nia, assist.prof. skin research center
Shahid Beheshti Medical University
October 2009

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