Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

Basal Cell Carcinoma Clinical Trial

Official title:

Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985829
• Other study ID #: pdt bcc1
• Status: Completed
• Phase: Phase 1
• First received: September 26, 2009
• Last updated: November 18, 2009
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2009
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Radiation:
• photodynamic therapy
treatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response to Photodynamic Therapy		immediately after termination of treatment course (with an average of 5 month after initiation of PDT)	Yes
Secondary	Histologic Resolution of Lesion		immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)	Yes