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

Catharina Hospital

Status and phase: Terminated; Phase 4

Conditions: Bowen's Disease

Treatments: Procedure: Photodynamic therapy; Procedure: excision

Study type: Interventional

Funder types: Other

Identifiers

NCT00472706

M06-16107

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

65 participants in 2 patient groups

1

Active Comparator group

Description:

Excision

Treatment:

Procedure: excision

2

Active Comparator group

Description:

Photodynamic therapy

Treatment:

Procedure: Photodynamic therapy