Clinical Trial to Assess Safety, Tolerability and the Pha... | NCT03898583

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Microarray patch A	Experimental	21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use	Drug: Microarray patch A
Microarray patch B	Experimental	21 day treatment, 3 times weekly, 9 applications in total, transdermal patch for cutaneous use	Drug: Microarray patch B
Vehicle	Placebo Comparator	21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use, no active substance	Drug: Placebo
Daivobet	Active Comparator	21 day treatment, paused on day 7, day 14 and day 21, Cutaneous use	Drug: Daivobet

Name	Type	Description	Arm Group Labels	Other Names
Microarray patch A	Drug	Microarray patch	Microarray patch A	Calcipotriol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall number of treatment-emergent adverse events.		First IMP application up to trial end (Day 50)
Number of treatment-emergent application site reactions, by treatment		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.	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.	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.	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'.	EoT (Day 22)
Change from baseline to Day 22 (EoT) in systolic and diastolic blood pressure.

Secondary Outcomes

Measure	Description	Time Frame
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).	EoT (Day 22)

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Subjects with psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) covering a sufficient area to allocate 4 test fields on up to 3 comparable plaques.
Men and women aged 18-70 years (inclusive).
Sufficient target lesion(s) must be present on the trunk or extremities (excluding palms/soles); psoriatic lesions on the knees or elbows are not to be used as target lesions.
Plaques to be treated should have a comparable thickness of the EPB of the inflammatory infiltrate of at least 200 μm.
Plaques to be treated should have no more than a 2-fold difference in infiltrate thickness between the test fields.
Physical examination of skin must be without abnormal, clinical significant findings other than psoriasis vulgaris unless the investigator considers an abnormality to be irrelevant to the trial outcome.

Key Exclusion Criteria:

Other skin disease noted on physical examination that is considered by the investigator to be relevant to the outcome of the trial.
Subjects with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis.
History of psoriasis that was unresponsive or poorly responsive to topical treatments.
Topical antipsoriatics are not permitted on the same body area as plaques to be treated during the 4 weeks before first treatment and during the trial.
Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids, dimethylfumarate, apremilast in the 3 months before first treatment and during the trial.
Systemic treatment with biological treatments: rituximab within 12 months, ustekinumab or secukinumab within 6 months before first treatment and during the trial.
Systemic treatment with biological treatments within 3 months before first treatment and during the trial.
Systemic treatment with any other biological treatments within the period of 5 half-lives of the biological before first treatment and during the trial.
UV-therapy or extensive exposure to UV radiation or sunlight within 4 weeks before first treatment and during the trial.
Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, unless on a stable dose for 3 months before trial medication initiation.
Any other topical medication on the plaques to be treated during the trial.
Clinically significant abnormal vital signs (blood pressure, and pulse) at screening (V1).
History/symptoms of a clinically significant illness before first treatment (past 5 years) and during the trial that in the investigator's opinion may place the subject at risk.
History/symptoms of a clinically significant illness before first treatment (past 5 years) and during the trial that in the investigator's opinion may influence the trial outcome.
Other clinically significant abnormal laboratory results.

Facility	Status	City	State	ZIP	Country	Contacts
LEO Pharma investigational site		Berlin		10783	Germany
LEO Pharma investigational site

ID	Term
C055085	calcipotriene
C011175	betamethasone-17,21-dipropionate
C517164	betamethasone dipropionate, calcipotriol drug combination