1404003_OpenPsori.PlaqueTest to Eval.Eff.of Diff.Comp. to Mapracorat
Status:
Completed
Trial end date:
2013-05-31
Target enrollment:
Participant gender:
Summary
Evaluation of efficacy and safety of Mapracorat 0.1% ointment and 4 comparator ointments in
male and female subjects 18 to 65 years with stable plaque-type psoriasis treated once daily
6 days a week for a maximum of 4 weeks.
Primary objective was to compare the efficacy of all test compounds by measurement of
psoriatic infiltrate thickness (PIT) with 20 MHz B mode ultrasound.
Secondary objectives were to assess safety of all test compounds by measurement of the
atrophogenic potential on non-lesional skin with 20 MHz B mode ultrasound, to assess the
efficacy of all test compounds by measurement of intensity of erythema measured by
chromametry, to assess the efficacy of all test compounds by visual assessment of the skin in
the test fields using a 5-point score, to assess the safety of all test compounds by visual
assessments of formation of teleangiectasia using a 5-point score, to assess the safety of
all test compounds by visual assessment of atrophy using a 5-point score, to assess the
safety of all test compounds by visual assessment of local tolerability using a 5-point
score, to visualize the therapeutic index given by PIT versus non lesional skin thickness.