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

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Basal Cell Carcinoma

Treatments: Radiation: photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00988455

zthr

pdt bcc 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

BCC, ALA-PDT

Experimental group

Description:

Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT

Treatment:

Radiation: photodynamic therapy