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Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

NCT ID: NCT00985829

Last Updated: 2009-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.

Detailed Description

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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 factors that may affect response rate.

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 and probable side effects.

Conditions

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Basal Cell Carcinoma

Keywords

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basal cell carcinoma photodynamic therapy photo chemotherapy basal cell epithelioma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BCC, ALA-PDT

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

Group Type EXPERIMENTAL

photodynamic therapy

Intervention Type RADIATION

treatment of bcc with 5\_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly

Interventions

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photodynamic therapy

treatment of bcc with 5\_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly

Intervention Type RADIATION

Other Intervention Names

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PDT 1200L Waldman Medizintechnik; Schwenningen, Germany

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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assistant professor of dermatology Shaheed Beheshti Medical University

Principal Investigators

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Zohreh Tehranchi-nia, assist.prof.

Role: PRINCIPAL_INVESTIGATOR

Skin Research Center

Other Identifiers

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NCT00985829

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

pdt bcc1

Identifier Type: -

Identifier Source: org_study_id