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NCT00472706 Clinical Trial

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

Bowen's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00472706
Other study ID # M06-16107
Secondary ID
Status Terminated
Phase Phase 4
First received May 10, 2007
Last updated May 12, 2010
Start date May 2007
Est. completion date February 2010

Study information
Verified date May 2010
Source Catharina Ziekenhuis Eindhoven
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 65
Est. completion date February 2010
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Procedure:
• excision
excision 3 mm margin
• Photodynamic therapy
Photodynamic therapy

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Catharina Ziekenhuis Eindhoven Erasmus Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary recurrence rate two years No
Secondary cosmetic outcome one year No
See also
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Completed NCT02085395 - Clinical Study Assessment of SR-T100 Topical Gel Against Actinic Keratosis Phase 2
Recruiting NCT03909646 - Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease Phase 4
Completed NCT04293679 - Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCC Phase 1/Phase 2
Completed NCT01912976 - Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Bowen's Disease Phase 1
Active, not recruiting NCT06014697 - OCT and Invasion in Cutaneous Skin Lesions
Completed NCT03167762 - Photographing the Skin During Photodynamic Therapy N/A
Recruiting NCT02759900 - Using a Cold Atmospheric Plasma Device to Treat Skin Disorders N/A
Recruiting NCT05402046 - Clinical vAlidation of a MobilE appLication ("ProRodinki") in the Assessment of the maLignant skIn neoplAsms N/A
No longer available NCT00535080 - Compassionate Use of Metvix® (Methyl Aminolevulinate) Photodynamic Therapy (PDT) in Subjects With Field Actinic Keratoses, Large/Multiple Superficial Basal Cell Carcinomas (BCCs), or Bowen's Disease