Excision versus PDT in the tratment of Bowen's disease. What's the best therapy on behalve of recurrence rate, cosmetic outcome and cost-utility.
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recurrence rate
Secondary outcome
Cosmetic outcome
Cost-utility
Background summary
A randomised clinical trial of excision versus photodynamic therapy in the
treatment of Bowen's disease
Bowen's disease is also called intraepithelial squamous cell carcinoma. It's a
form of skincancer restricted to the epidermis. There is however a risk of
progressing to invasive squamous cell carcinoma and metastasizing. The risk of
getting invasive lies around 3 %. There are many different treatment
modalities for the diseasevoor de aandoening, for example excision,
photodynamic therapy (PDT), 5-Fluorouracil, curettage, electrocoagulation and
laser. All treatments show the sam recurrence rates of 5-15 %. There are
however few randomised prospective clinical trials, which can give a wrong
presentation. In our study we want to compare the two most used therapies in
the treatment of Bowen's disease, excision and PDT, within recurrence rate,
cosmetic outcome and cost-utility.
Study objective
Excision versus PDT in the tratment of Bowen's disease. What's the best therapy
on behalve of recurrence rate, cosmetic outcome and cost-utility.
Study design
Prospective randomised clinical trial: excision versus PDT
-Questionnaires about general health and functioning, treatment(experience) and
cosmetic outcome.
-Clinical follow-up to detect recurreces
Intervention
Excision or PDT
Study burden and risks
Not applicable
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
Histopathologic proven Bowen's disease scalp, face, torso, arms and legs
Age > 18 years
Informed consent
Exclusion criteria
Recurrent Bowen's disease
Anogenital or subungual Bowen's disease
Other skin malagnancies in the same area
Porfyria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-006430-18-NL |
| CCMO | NL15192.060.06 |