The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch biopsies).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
1-2 times during the treatment time
once daily
Almirall investigative site 3
Dülmen, Germany
Almirall investigative site 1
Leipzig, Germany
Almirall investigative site 4
Soest, Germany
Almirall investigative site 2
Wuppertal, Germany
Histological status (AK diagnosis and grade) of one predefined target lesion
Histological clearance at 8 weeks after end of treatment with LAS 41005, respectively 14 weeks after first cryotherapy. Histological Status will be measured by Histological Biopsy in order to confirm the diagnosis of AK and the grade.
Time frame: Screening and 8 weeks after last treatment
Total Actinic keratoses (AK)lesion count at each visit
The clearance rate (complete/partial) of AK lesions (determined by clinical evaluation) in the treatment area (target areas A and B) will be measured by comparing the total AK lesion counts pre-treatment (on Day 1 before study treatment has been applied) with the lesion counts measured.
Time frame: day 1, day 21, day 42 and day 98.
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