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

Phase 4

Terminated

• Conditions: Bowen's Disease
• Interventions: Procedure: excision; Procedure: Photodynamic therapy

• Registration Number: NCT00472706
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-10
• Study First Submitted QC: 2007-05-10
• Study First Posted: 2007-05-14
• Primary Completion: 2009-02
• Study Completion: 2010-02
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-12
• Last Update Posted: 2010-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	excision	Excision
2	Photodynamic therapy	Photodynamic therapy

Primary Outcome Measures

Name	Time	Method
recurrence rate	two years

Secondary Outcome Measures

Name	Time	Method
cosmetic outcome	one year