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Short Term Effects of Photodynamic Therapy in Basal Cell Carcinoma

NCT ID: NCT01015898

Last Updated: 2009-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

2008-09-30

Brief Summary

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The purpose of this study is to evaluate the efficacy of photodynamic therapy in treatment of Basal cell carcinoma (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, Villengen; 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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NCT00985830

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

pdt1

Identifier Type: -

Identifier Source: org_study_id