Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up
Phase 1
Completed
- Conditions
- Basal Cell Carcinoma
- Interventions
- Radiation: photodynamic therapy
- Registration Number
- NCT00988455
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BCC, ALA-PDT photodynamic therapy Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT
- Primary Outcome Measures
Name Time Method response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination) 1 year
- Secondary Outcome Measures
Name Time Method recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up 1 year