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

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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