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

October 1, 2009 updated by: Shahid Beheshti University of Medical Sciences
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • PDT 1200L Waldman Medizintechnik, Villengen; Schwenningen, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Zohreh Tehranchi-nia, assist.prof., Skin Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (Estimate)

October 2, 2009

Study Record Updates

Last Update Posted (Estimate)

October 2, 2009

Last Update Submitted That Met QC Criteria

October 1, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pdt bcc 2
  • zthr

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe