Comparing surgical excision with photodynamic therapy and 5-Fluorouracil in treatment of Bowen'disease.
- Conditions
- Bowens's diseaseTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-004685-33-NL
- Lead Sponsor
- azM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 168
-Adults = 18 years
-Histologically proven primary Bowen’s disease
-Lesions = 4mm and = 40mm in diameter
-Fitzpatrick skin type I-IV
-Female in child bearing potential should be using contraceptive measures, during and till 3 months post-treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 118
-Bowen's Disease located at ears, periocular, nail , nail unit or periungual tissue, nose (limited light exposure for PDT) and mucous membranes (different entities)
-High clinical suspicion of invasive SCC
-(N)MSC in target area
-Breastfeeding
-Pregnancy
-Allergy to study drugs
-Not able to self-apply cream on lesions located on the back or other difficult to reach locations
-Genetic skin cancer disorders
-Not understanding Dutch language
-Porphyria
-Not able to give informed consent
-Immuno-compromised status
-Use of systemic retinoid in the past 3 months
-Use of immunosuppressant drugs in the past 3 months and / or at time of treatment (such as oral glucocorticoids, cytostatic, antibodies, drug acting on immunophilins, in-terferon, opioids, TNF binding proteins, MMF, biologic agents). inhalation corticoster-oids / nasal corticosteroids are permitted.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method