To investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris
The study will be performed in 12 male subjects with stable psoriatic plaques. The study preparations and the comparators will be tested observer-blind. Treatments will be randomly assigned to the test fields. All subjects will receive all treatments, with intraindividual comparison of the treatments. Altogether six test fields will be examined per subject (three active AN2728 ointments of different concentrations: 5 %, 2 % and 0.5 %, the active ingredient-free vehicle, a marketed corticoid preparation and a marketed topical immunomodulator). The test fields will be treated occlusively over a study period of 12 days. A topical application of approximately 200 uL of each assigned intervention will be administered per treatment, for a total of 10 treatments over a 12-day treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
Bioskin GmbH
Hamburg, Germany
Efficacy of the Active Study Preparations Compared to the Corresponding Vehicle Using Differences in Infiltrate Thickness on Study Day 12
Time frame: Day 12
Change in Infiltrate Thickness
Time frame: Day 8
Sonographic Measurements of Infiltrate Thickness
Time frame: Day 8, Day 12
The AUC of the Infiltrate Thickness
Time frame: Day 8, Day 12
Clinical Assessment Scores for Assessment of Efficacy
Time frame: Day 8, Day 12
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