Bowen's DiseasePhase 4NCT00472706
Trial of Excision Versus Photodynamic Therapy in the Treatment of Bowen's Disease
A Phase 4 study testing excision and Photodynamic therapy in people with Bowen's Disease, run by Catharina Ziekenhuis Eindhoven.
Trial summary
The purpose of this study is to identify the most optimal therapy for Bowen's disease: excision versus Photodynamic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowen's Disease
- What is being tested?
- excision and Photodynamic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Feb 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Histological proven Bowen's disease on scalp, face, trunk, arms and legs
- Informed Consent
Who cannot join
- Recurrent Bowen's disease
- Anogenital or subungual Bowe's disease
- Other skin malignancy in the same area
- Porphyria
About this study
Official title: A Randomized Clinical Trial of Excision Versus Photodynamic Therapy in Bowen's Disease
The purpose of this study is to identify the most optimal therapy for Bowen's disease: excision versus Photodynamic therapy.
Read the detailed 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.
- Conditions
- Bowen's Disease
- Being tested
- excision, Photodynamic therapy
- Keywords
- Treatment, Excision, Photodynamic therapy, Recurrence rate, Cosmetic outcome
- Medical subject headings
- Bowen's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
excisionProcedure or surgery
excision 3 mm margin
Photodynamic therapyProcedure or surgery
Photodynamic therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Excision Receives: Procedure: excision |
| 2 | Active comparator | Photodynamic therapy Receives: Procedure: Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
Measured: two years
Secondary outcomes (1)
cosmetic outcome
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2010
Why it stopped: Study stopped because of disappointing inclusion rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowen's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Investigators
- Annette Verzijl, MD, Principal investigator, Catharina hospital/Erasmus MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472706
- Sponsor's protocol ID
- M06-16107
- Status last verified
- May 2010
- First submitted
- 10 May 2007
- Last updated
- 13 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Excision Versus Photodynamic Therapy in Bowen's Disease
- ClinicalTrials.gov ID
- NCT00472706
- Acronym / sponsor ID
- M06-16107
- Conditions
- Bowen's Disease
- Keywords
- Treatment, Excision, Photodynamic therapy, Recurrence rate, Cosmetic outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped because of disappointing inclusion rates
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- May 2007
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2010 (actual)
- First posted
- 14 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify the most optimal therapy for Bowen's disease: excision versus Photodynamic therapy.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: excisionExcision |
| 2 | Active comparator | Procedure: Photodynamic therapyPhotodynamic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Histological proven Bowen's disease on scalp, face, trunk, arms and legs
- Informed Consent
Key exclusion criteria (4 listed)
- Recurrent Bowen's disease
- Anogenital or subungual Bowe's disease
- Other skin malignancy in the same area
- Porphyria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| excisionexcision 3 mm margin | Procedure or surgery | 1 |
| Photodynamic therapyPhotodynamic therapy | Procedure or surgery | 2 |
Primary outcome
recurrence rate
Time frame: two years
1 secondary outcome
cosmetic outcome
Time frame: one year
Results and safety
The study was stopped early (reason given: Study stopped because of disappointing inclusion rates). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2010.
Related trials for Bowen's Disease
Not yet recruiting
High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and Bowen's Disease in Adults
Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Verzijl, MD principal investigator
Catharina hospital/Erasmus MC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing excision and Photodynamic therapy in people with Bowen's Disease, run by Catharina Ziekenhuis Eindhoven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study stopped because of disappointing inclusion rates). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2010.