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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
0.1% (1 mg/g) of the active ingredient mapracorat plus excipients as ointment
0.25% (2.5 mg/g) of the active ingredient prednicarbate as ointment
0.05% (0.5 mg/g) of the active ingredient clobetasol as ointment
0.005% (0.05 mg/g) of the active ingredient calcipotriene as ointment
0.005% (0.05 mg/g) of the active ingredient calcipotriene/0.05% (0.5 mg/g) of the active ingredient betamethasone dipropionate as ointment
Unnamed facility
Hamburg, Germany
Baseline-corrected area under the curve of the psoriatic infiltrate thickness (PIT) measured by 20 MHz B mode ultrasound
Assessment was done on the test fields on psoriatic plaques
Time frame: Prior to drug application from Day 1 and up to Day 29
Skin thickness measurement of occluded test field on non-lesional skin (mean of triplicate measurement)
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Time frame: Prior to drug application from Day 1 up to Day 60
Clinical assessment of atrophy using a 5-point score
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Time frame: Prior to drug application from Day 1 and up to Day 29
Clinical assessment of telangiectasia using a 5-point score
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Time frame: Prior to drug application from Day 1 and up to Day 29
Clinical assessment of local tolerability using a 5-point score
Assessment was made on occluded test fields on non-lesional skin areas on the forearm
Time frame: Prior to drug application from Day 1 and up to Day 29
PIT measured by 20 MHz B mode ultrasound
Assessment was done on the test fields on psoriatic plaques
Time frame: Prior to drug application from Day 1 and up to Day 29
Measurement of erythema using chromametry (mean of triplicate measurement)
Assessment was done on the test fields on psoriatic plaques
Time frame: Prior to drug application from Day 1 and up to Day 29
Clinical efficacy assessment of the skin in the test fields using a 5-point score
Assessment was done on the test fields on psoriatic plaques
Time frame: Prior to drug application from Day 1 and up to Day 29
Number of participants with adverse events
Time frame: Approximately 64-84 days
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