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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photodynamic therapy

Radiation

5-ALA cream 20% topical administration + photodynamic therapy (red light) 120 j/cm2

Other names: PDT 1200L Waldman Medizintechnik, Villengen; Schwenningen, Germany

Primary outcomes

response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination)

Time frame: 1 year

Secondary outcomes

recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Oct 2, 2009
Registry last updated: Oct 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed