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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00988455
First received: September 29, 2009
Last updated: October 1, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Basal Cell Carcinoma
Radiation: photodynamic therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: January 2008
Study Completion Date: August 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PDT 1200L Waldman Medizintechnik, Villengen; Schwenningen, Germany

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988455

Sponsors and Collaborators
Shahid Beheshti Medical University
Investigators
Principal Investigator: zohreh Tehranchi-nia, assist.prof. skin research center
  More Information

No publications provided

Responsible Party: Zohreh Tehranchi-nia, assistant professor of dermatology
ClinicalTrials.gov Identifier: NCT00988455     History of Changes
Other Study ID Numbers: pdt bcc 2, zthr
Study First Received: September 29, 2009
Last Updated: October 1, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
basal cell carcinoma
photodynamic therapy
photo chemotherapy
basal cell epithelioma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on August 28, 2014