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Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Basal Cell Carcinoma

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Trial Information


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

zohreh Tehranchi-nia, assist.prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

skin research center

Authority:

Iran: Ethics Committee

Study ID:

pdt bcc 2

NCT ID:

NCT00988455

Start Date:

January 2008

Completion Date:

August 2009

Related Keywords:

  • Basal Cell Carcinoma
  • basal cell carcinoma
  • photodynamic therapy
  • photo chemotherapy
  • basal cell epithelioma
  • Carcinoma
  • Carcinoma, Basal Cell

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