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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014