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

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ClinicalTrials.gov Identifier: NCT00472706
Recruitment Status : Terminated (Study stopped because of disappointing inclusion rates)
First Posted : May 14, 2007
Last Update Posted : May 13, 2010
Erasmus Medical Center
Information provided by:
Catharina Ziekenhuis Eindhoven

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

Condition or disease Intervention/treatment Phase
Bowen's Disease Procedure: excision Procedure: Photodynamic therapy Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
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
Study Start Date : May 2007
Estimated Primary Completion Date : February 2009
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Procedure: excision
excision 3 mm margin
Active Comparator: 2
Photodynamic therapy
Procedure: Photodynamic therapy
Photodynamic therapy

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

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

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

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

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
Principal Investigator: Annette Verzijl, MD Catharina hospital/Erasmus MC

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

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

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