Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II
To investigate as primary objective:
- Superiority to placebo and non-inferiority to LAS106521 measured by histological
clearance of one predefined target lesion;
To investigate as secondary objective:
- Superiority to LAS106521
- Improvement of treated lesions (lesion response)
- Assessment of tolerability and safety by physicians global assessment score (PGA, PGT)
- Patient's assessment of tolerability and efficacy and patient's compliance
Main
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Histological status of AK target lesion
Day 140
No
Christoph Willers, MD, MBA
Study Director
Almirall Hermal GmbH
Germany: Federal Institute for Drugs and Medical Devices
H 1005 6002 - 0702
NCT00987246
June 2008
June 2009
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