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:
Collaborator:
Erasmus Medical Center
Information provided by:
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT00472706
First received: May 10, 2007
Last updated: May 12, 2010
Last verified: May 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cosmetic outcome [ Time Frame: one year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00472706

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

No publications provided

Responsible Party: Drs. A. Verzijl, Catharina hospital/Erasmus MC
ClinicalTrials.gov Identifier: NCT00472706     History of Changes
Other Study ID Numbers: M06-16107
Study First Received: May 10, 2007
Last Updated: May 12, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on April 21, 2014