Psoriasis Vulgaris
Conditions
Brief summary
To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.
Interventions
DRUGLEO 134310
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
DRUGLEO 134310 vehicle
Active substance: none
DRUG0.1% betamethasone valerate ointment (class III steroid)
Active substance: betamethasone valerate
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The trial will be performed investigator-blind with random assignment of the 4 Investigational Medicinal Products (IMPs), the placebo and the active comparator.
Intervention model description
Intra-individual comparison of all treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Subjects aged 18-64 years (inclusive) with plaque psoriasis in a chronic stable phase. * Men or women of non-child bearing potential.
Exclusion criteria
* Acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis. * According to defined washout periods: topical antipsoriatic drugs (except salicylic acid in petroleum jelly); systemic antipsoriatics and biologics; ultraviolet (UV) therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with abnormal clinically significant findings of physical examination at Day 12. | Up to 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' |
| Change from baseline to Day 4, Day 8 and Day 12 in urinalysis parameters | Up to Day 12 | 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 |
| Number of subjects with abnormal clinical significant ECG evaluation | Up to Day 12 | Evaluation of 12-lead ECG (overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant') |
| Change from baseline to Day 4, Day 8, Day 12 in systolic and diastolic blood pressure. | Up to Day 12 | measured in mmHg |
| Change from baseline to Day 4, Day 8 and Day 12 in oral body temperature. | Up to Day 12 | measured in degrees celsius |
| Change from baseline to Day 4, Day 8 and Day 12 in pulse. | Up to Day 12 | measured in beats per minute |
| Overall number of treatment-emergent adverse events. | Up to Day 19 | — |
| Number of treatment-emergent application site reactions, by treatment. | Up to Day 19 | — |
| Change from baseline to Day 4, Day 8 and Day 12 in haematology parameters | Up to Day 12 | red blood cells, white blood cells, hemoglobin, hematocrit, MCH, MMCV, MCHC, platelets, white cell differentials, measure in SI units |
| Change from baseline to Day 4, Day 8 and Day 12 in clinical chemistry parameters | Up to Day 12 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to Day 12 in disease severity | 12 days | 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') |
| 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) | 12 days | — |
Countries
Germany
Outcome results
None listed