Treatment of superficial basal cell carcinoma by topical photodynamic therapy with fractionated 5-aminolevulinic acid 20% versus two stage topical photodynamic therapy with methylaminolevulinate
Phase 3
Recruiting
- Conditions
- Basal cell carcinomaskin cancer10040900
- Registration Number
- NL-OMON50578
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 162
Inclusion Criteria
Minimal age of 18 years
Histological proven sBCC
Primary sBCC (no previous treatment)
Being able to understand instructions
Exclusion Criteria
Age under 18 years
No histological proven sBCC
Recurrent sBCC (previously treated)
Not able to understand instructions
Concomitant disease requiring systematic immunosuppressive treatment
Genetic skin cancer disorders
Pregnant women
Breastfeeding women
Porphyria
Allergy for photosensitizer components
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Treatment failure 5 years after treatment of sBCC with fractionated 5-ALA 20%<br /><br>PDT versus MAL PDT in 2 sessions.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Degree of pain during treatment, side-effects of treatments, patient<br /><br>preferences and health care costs of treatment with fractionated 5-ALA 20% PDT<br /><br>versus MAL PDT in 2 sessions. </p><br>