Actinic Keratosis Clinical Trial
Official title:
Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II
The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).
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
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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