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A Randomized Clinical Trial of Excision Versus Photodynamic Therapy in Bowen's Disease


Phase 4
18 Years
N/A
Not Enrolling
Both
Bowen's Disease

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Trial Information

A Randomized Clinical Trial of Excision Versus Photodynamic Therapy in Bowen's Disease


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

recurrence rate

Outcome Time Frame:

two years

Safety Issue:

No

Principal Investigator

Annette Verzijl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Catharina hospital/Erasmus MC

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

M06-16107

NCT ID:

NCT00472706

Start Date:

May 2007

Completion Date:

February 2010

Related Keywords:

  • Bowen's Disease
  • Treatment
  • Excision
  • Photodynamic therapy
  • Recurrence rate
  • Cosmetic outcome
  • Bowen's Disease

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