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

This study has been terminated.
(Study stopped because of disappointing inclusion rates)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00472706
First Posted: May 14, 2007
Last Update Posted: May 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Erasmus Medical Center
Information provided by:
Catharina Ziekenhuis Eindhoven
  Purpose
The purpose of this study is to identify the most optimal therapy for Bowen's disease: excision versus Photodynamic therapy.

Condition Intervention Phase
Bowen's Disease Procedure: excision Procedure: Photodynamic therapy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Excision Versus Photodynamic Therapy in Bowen's Disease

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • recurrence rate [ Time Frame: two years ]

Secondary Outcome Measures:
  • cosmetic outcome [ Time Frame: one year ]

Enrollment: 65
Study Start Date: May 2007
Study Completion Date: February 2010
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Excision
Procedure: excision
excision 3 mm margin
Active Comparator: 2
Photodynamic therapy
Procedure: Photodynamic therapy
Photodynamic therapy

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472706


Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Erasmus Medical Center
Investigators
Principal Investigator: Annette Verzijl, MD Catharina hospital/Erasmus MC
  More Information

Responsible Party: Drs. A. Verzijl, Catharina hospital/Erasmus MC
ClinicalTrials.gov Identifier: NCT00472706     History of Changes
Other Study ID Numbers: M06-16107
First Submitted: May 10, 2007
First Posted: May 14, 2007
Last Update Posted: May 13, 2010
Last Verified: May 2010

Keywords provided by Catharina Ziekenhuis Eindhoven:
Treatment
Excision
Photodynamic therapy
Recurrence rate
Cosmetic outcome

Additional relevant MeSH terms:
Bowen's Disease
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell