Treatment of superficial basal cell carcinoma by three non-invasive modalities: PDT vs. imiquimod vs. 5-fluorouracil - Treatment of sBCC
- Conditions
- superficial basal cell carcinoma
- Registration Number
- EUCTR2007-002776-33-NL
- Lead Sponsor
- Academic hospital Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
All patients with a primary (no previous treatment) histopathologically confirmed diagnosis of one or more sBCCs aged between 18 and 80 years old.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients:
- using immunosuppressive drugs
- genetic skin cancer disorders
- location in the H-zone or the hairy head
- earlier treatments at the same site
- with pigmented BCCs
- with light sensitive disease
- uncapable of self treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This research has the goal to determine which treatment is the most effective treatment in terms of prevention of treatment failure, in costs and has the patients preference when comparing PDT, Imiquimod and 5FU.The primary outcome measure is treatment failure within 12 months after treatment. ;Secondary Objective: Secondary outcome measures are degree of pain experienced during treatment, compliance with treatment, side effects of treatment, patient preferences and health care costs. ;Primary end point(s): Treatment failure within 12 months after treatment. Treatment failure is defined as the presence of clinically and histologically confirmed sBCC.<br>Assessment of the primary outcome (treatment failure) will be performed by an independent observer, who is blinded to the assigned treatment modality and is not involved in the treatment, at 3 months and at 1 year after treatment. In addition, digital photographs will be taken at baseline and in case of a treatment failure or complication.<br>
- Secondary Outcome Measures
Name Time Method