Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988455
|Principal Investigator:||zohreh Tehranchi-nia, assist.prof.||skin research center|