NCT00472706

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2007

Typical duration for phase_4

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

May 13, 2010

Status Verified

May 1, 2010

Enrollment Period

1.8 years

First QC Date

May 10, 2007

Last Update Submit

May 12, 2010

Conditions

Bowen's Disease

Keywords

TreatmentExcisionPhotodynamic therapyRecurrence rateCosmetic outcome

Outcome Measures

Primary Outcomes (1)

  • recurrence rate

    two years

Secondary Outcomes (1)

  • cosmetic outcome

    one year

Study Arms (2)

1

ACTIVE COMPARATOR

Excision

Procedure: excision

2

ACTIVE COMPARATOR

Photodynamic therapy

Procedure: Photodynamic therapy

Interventions

excisionPROCEDURE

excision 3 mm margin

1
Photodynamic therapyPROCEDURE

Photodynamic therapy

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Histological proven Bowen's disease on scalp, face, trunk, arms and legs
  • Informed Consent

You may not qualify if:

  • Recurrent Bowen's disease
  • Anogenital or subungual Bowe's disease
  • Other skin malignancy in the same area
  • Porphyria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bowen's Disease

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Annette Verzijl, MD

    Catharina hospital/Erasmus MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 14, 2007

Study Start

May 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2010

Last Updated

May 13, 2010

Record last verified: 2010-05