To assess safety, tolerability and pharmacodynamics effect of treatment with microarray patches containing calcipotriol and betamethasone dipropionate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
LEO Pharma investigational site
Berlin, Germany
LEO Pharma investigational site
Hamburg, Germany
Overall number of treatment-emergent adverse events.
Time frame: First IMP application up to trial end (Day 50)
Number of treatment-emergent application site reactions, by treatment
Time frame: First IMP application up to trial end (Day 50)
Change from baseline to Day 22 (EoT) in haematology parameters.
RBC, WBC, haemoglobin, haematocrit, platelets, white cell differentials; measured in SI units.
Time frame: From baseline up to EoT (Day 22)
Change from baseline to Day 22 (EoT) in clinical chemistry parameters.
Sodium, potassium, BUN, glucose, AST, ALT, gamma GT, AP, calcium, phosphate, albumin, total cholesterol, LDH, total protein, creatinine, total bilirubin; measured in SI units.
Time frame: From baseline to EoT (Day 22)
Change from baseline to Day 22 (EoT) in urinalysis parameters, single parameters only to be listed if deviation from usual urine dip test.
E.g., leukocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin, measured in SI units.
Time frame: From baseline to EoT (Day 22)
Number of subjects with abnormal clinically significant findings of physical examination at Day 22 (EoT).
Evaluation of physical examination (areas skin, heart, lung, abdomen, basic neurological status, general examination of eyes, ears, nose, throat), overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant'.
Time frame: EoT (Day 22)
Change from baseline to Day 22 (EoT) in systolic and diastolic blood pressure.
Measured in mmHg.
Time frame: From baseline to EoT (Day 22)
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Daivobet Gel
Change from baseline to Day 22 (EoT) in pulse.
Measured in beats per minute.
Time frame: From baseline to EoT (Day 22)
Frequency counts of overall tolerability assessment of skin reactions at Day 8, Day 15, Day 22, Day 36 and Day 50.
(Assessment performed by an investigator using a 4-point score \['0 = very good', '1 = good', '2 = moderate', '3 = poor'\]).
Time frame: From baseline up to trial end (Day 50)
Change from baseline (pre-dose at Day 1) to Day 22 (EoT) in psoriatic infiltrate thickness.
(Assessed by measurement of the thickness of the Echo Poor Band \[EPB\] of the inflammatory infiltrate using 22-MHz sonography; measured in µm).
Time frame: EoT (Day 22)