The aim of the exploratory study is to compare dose related effects of LAS41004 formulations in a non-occlusive PPT.
Going for a non-occlusive application design will allow to draw practical conclusions as being similar to a real treatment situation (compared with a occluded design to maximise effects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
22
once daily, topical ointment, 100 microgram per day
Investigational site
Schenefeld, Germany
Decrease of skin thickness(AUC, area under the curve)
Measurement of skin thickness will be performed by ultrasound (distance between lower border of entry echo and lower border of dermis). The area under the curve, AUC, from day 1 to day 22 will be compared to the reference formulations.
Time frame: day 1 to day 22
Decrease in scaling
scoring of scaling (score 0-4) will be performed by investigator
Time frame: baseline vs day 22
decrease in erythema
scoring of erythema (score 0-4) wil be performed by investigator
Time frame: baseline vs day 22
decrease of induration
scoring of induration (score 0-4) will be performed by investigator
Time frame: baseline vs day 22
assessment of (s)AE
a daily record will be performed and if needed the severity and causality assessed
Time frame: from baseline to day 22
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