Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

Phase 1

Completed

• Conditions: Basal Cell Carcinoma
• Interventions: Radiation: photodynamic therapy

• Registration Number: NCT00985829
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2008-07
• Study Completion: 2009-03
• Study First Submitted: 2009-09-26
• Study First Submitted QC: 2009-09-26
• Study First Posted: 2009-09-28
• Results First Submitted: 2009-09-30
• Status Verified: 2009-11
• Results First Submitted QC: 2009-11-18
• Last Update Submitted: 2009-11-18
• Results First Posted: 2009-12-22
• Last Update Posted: 2009-12-22

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
Clinical Response to Photodynamic Therapy	immediately after termination of treatment course (with an average of 5 month after initiation of PDT)	categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced

Secondary Outcome Measures

Name	Time	Method
Histologic Resolution of Lesion	immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)	disappearance of the lesion in histologic examination