Treatment of Actinic keratosis: topical ingenol mebutate versus 5%5-fluorouracil versus 5% imiquimod versus photodynamic therapy.
- Conditions
- Actinic keratosis
- Registration Number
- NL-OMON22756
- Lead Sponsor
- K. Mosterd, dermatologistMaastricht University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 624
Inclusion Criteria
Patients older than 18 years
- Female in child bearing potential should be using contraceptive measures, during and till 3 months post-treatment
Exclusion Criteria
- Received any kind of treatment for AK in the past 3 months
- (N)MSC in target area
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measure: treatment success (i.e. the proportion of patients with >75% lesion reduction in the number of AK lesions counted at baseline in the treatment area) 12 months post treatment.
- Secondary Outcome Measures
Name Time Method - Partial response (proportion of participants at 12 months post treatment with 50-75% reduction in number of AK lesions)<br /><br>- Treatment failure (proportion of participants at 12 months post treatment with <50% reduction in number of AK lesions)<br /><br>- Complete lesion clearance (proportion of lesions with 100% clearance in all treated patients per study arm)<br /><br>- Partial lesion clearance (proportion of lesions with >75% clearance in all treated patients per study arm)<br /><br>- Decrease in number AK from baseline per patient<br /><br>- Number of SCC¡¯s developing in the treatment area<br /><br>- Healthcare/treatment costs<br /><br>- Side effects<br /><br>- Patient satisfaction<br /><br>- Cosmetic outcome <br /><br>- Treatment compliance