To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
13
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany
Investigational Site
Hamburg, Germany
Overall number of treatment-emergent adverse events.
Time frame: Up to Day 19
Number of treatment-emergent application site reactions, by treatment.
Time frame: Up to Day 19
Change from baseline to Day 4, Day 8 and Day 12 in haematology parameters
red blood cells, white blood cells, hemoglobin, hematocrit, MCH, MMCV, MCHC, platelets, white cell differentials, measure in SI units
Time frame: Up to Day 12
Change from baseline to Day 4, Day 8 and Day 12 in clinical chemistry parameters
sodium, potassium, chloride, bicarbonate, blood urea nitrogen, glucose, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gammaGT, uric acid, calcium, phosphate, albumin, triglycerides, cholesterol, lactate dehydrogenase, total protein, creatinine, total bilirubin, direct bilirubin, indirect bilirubin
Time frame: Up to Day 12
Change from baseline to Day 4, Day 8 and Day 12 in urinalysis parameters
Single parameters only to be listed if deviation from usual urine dip test, e.g., sediment, leucocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin
Time frame: Up to Day 12
Number of subjects with abnormal clinical significant ECG evaluation
Evaluation of 12-lead ECG (overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant')
Time frame: Up to Day 12
Number of subjects with abnormal clinically significant findings of physical examination at Day 12.
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'
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Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
Active substance: none
Active substance: betamethasone valerate
Time frame: Up to Day 12
Change from baseline to Day 4, Day 8, Day 12 in systolic and diastolic blood pressure.
measured in mmHg
Time frame: Up to Day 12
Change from baseline to Day 4, Day 8 and Day 12 in pulse.
measured in beats per minute
Time frame: Up to Day 12
Change from baseline to Day 4, Day 8 and Day 12 in oral body temperature.
measured in degrees celsius
Time frame: Up to Day 12
Change from baseline to Day 4, Day 8 and Day 12 in psoriatic infiltrate thickness (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography)
Time frame: 12 days
Change from baseline to Day 12 in disease severity
Clinical assessment of change in disease severity (a global assessment performed by an investigator using a 5-point score ('-1 = worsened', '0 = unchanged', '1 = slight improvement', '2 = clear improvement but not completely healed', '3 = completely healed')
Time frame: 12 days