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

Basal Cell Carcinoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988455
• Other study ID #: pdt bcc 2
• Secondary ID: zthr
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 29, 2009
• Last updated: October 1, 2009
• Start date: January 2008
• Est. completion date: August 2009

Study information

• Verified date: October 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 photodynamic therapy (PDT)in treatment of Basal cell carcinoma (BCC) and recurrence rate after 6 months.

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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2009
• Est. primary completion date: March 2009
• 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
5-ALA cream 20% topical administration + photodynamic therapy (red light) 120 j/cm2

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	response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination)		1 year	Yes
Secondary	recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up		1 year	Yes