The aim of this study is to determine the efficacy, safety and tolerability of LAS41007 compared to a marketed reference product as well as to vehicle (topical application, twice daily, indication mild to moderate AK).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
889
Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².
Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².
Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².
Almirall Investigational Site
Vechta, Germany
superiority of LAS41007 compared to vehicle
superiority of LAS41007 compared to comparator each assessed by histology to evaluate the histological clearance of one pre-selected target lesion
Time frame: Day 1
superiority of LAS41007 compared to vehicle
superiority of LAS41007 compared to comparator each assessed by histology to evaluate the histological clearance of one pre-selected target lesion
Time frame: Day 150
superiority of LAS41007 compared to vehicle
improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy
Time frame: Day 1
superiority of LAS41007 compared to vehicle
improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy
Time frame: Day 21
superiority of LAS41007 compared to vehicle
improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy
Time frame: Day 56
superiority of LAS41007 compared to vehicle
improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy
Time frame: Day 90
superiority of LAS41007 compared to vehicle
improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy
Time frame: Day 150
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