Efficacy of Actikerall® in patients with actinic keratosis (clinical grade I or II according to Olsen) in relation to treatment duratio
- Conditions
- Actinic keratosisL57.0
- Registration Number
- DRKS00004969
- Lead Sponsor
- Almirall Hermal GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1051
Inclusion Criteria
Enrolled patients are to be immune-competent, adult patients suffering from actinic keratosis (clinical stage I or II according to Olsen), who are to be treated with Actikerall® based upon physicians´ therapeutic decision.
Exclusion Criteria
*hypersensitivity to fluorouracil or salicylic acid
*planned or existing pregnancy or nursing period
*renal insufficiency
*(pre-)medication containing brivudine, sorivudine or analogs, that has been terminated less than four weeks prior to therapy start with Actikerall®
*immune suppression
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Description of efficacy of Actikerall® therapy in patients with actinic keratosis (clinical grade I or II according to Olsen) in relation to treatment duration in routine medical treatment. <br>Matter of particular interest are clinical changes in lesions under therapy with Actikerall® and beyond end of therapy. Measured values are current findings (total number, mean size (in mm) and changes in lesions determined by clinical examination and physician´s assessment of Actikerall® (efficacy, tolerance and patient compliance) by means of scales. Values are measured at baseline examination, optional interim examination, final examination (at end of therapy) and final assessment (about eight weeks after final examination). Collected data is documented in a standardized CRF-form.
- Secondary Outcome Measures
Name Time Method Additional end-point to be investigated are duration of therapy under Actikerall® (mean duration of therapy) as well as patients´ satisfaction and handling of Actikerall® determined by means of a standardized questionnaire. The questionnaire is handed out to the patient for completion at baseline examination and will be returned at the respective following examination.