Trial of Excision Versus Photodynamic Therapy in the Treatment of Bowen's Disease

NCT ID: NCT00472706

Last Updated: 2010-05-13

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to identify the most optimal therapy for Bowen's disease: excision versus Photodynamic therapy.

Detailed Description

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The study is a randomized clinical trial in which two treatment options for Bowen's disease, excision and photodynamic therapy, are compared on recurrence rate, cosmesis en expenses.

Conditions

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Bowen's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Excision

Group Type ACTIVE_COMPARATOR

excision

Intervention Type PROCEDURE

excision 3 mm margin

2

Photodynamic therapy

Group Type ACTIVE_COMPARATOR

Photodynamic therapy

Intervention Type PROCEDURE

Photodynamic therapy

Interventions

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excision

excision 3 mm margin

Intervention Type PROCEDURE

Photodynamic therapy

Photodynamic therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Histological proven Bowen's disease on scalp, face, trunk, arms and legs
* Informed Consent

Exclusion Criteria

* Recurrent Bowen's disease
* Anogenital or subungual Bowe's disease
* Other skin malignancy in the same area
* Porphyria
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Responsible Party

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Catharina hospital/Erasmus MC

Principal Investigators

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Annette Verzijl, MD

Role: PRINCIPAL_INVESTIGATOR

Catharina hospital/Erasmus MC

Other Identifiers

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M06-16107

Identifier Type: -

Identifier Source: org_study_id

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