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 )

First Received on May 10, 2007. Last Updated on May 12, 2010 History of Changes

Sponsor:	Catharina Ziekenhuis Eindhoven
Collaborator:	Erasmus Medical Center
Information provided by:	Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:	NCT00472706

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 IV

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:

MedlinePlus related topics: Cosmetics

U.S. FDA Resources

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 February 09, 2012