Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamics Effect of Calcipotriol/Betamethasone Dipropionate in a New Administration Form in Subjects With Chronic Plaque Psoriasis.
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|ClinicalTrials.gov Identifier: NCT03898583|
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : September 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Vulgaris||Drug: Microarray patch A Drug: Microarray patch B Drug: Placebo Drug: Daivobet||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Intra-individual comparison of all treatments|
|Masking Description:||The trial will be assessor-blinded with random assignment of the 2 microarray patches containing calcipotriol and betamethasone dipropionate, the vehicle (microarray patches without active substance) and the active comparator.|
|Official Title:||A Phase 1b, Randomised, Controlled, Assessor-blinded Proof of Principle Trial to Assess Safety, Tolerability and Pharmacodynamics Effects of Microarray Patches Containing Calcipotriol/Betamethasone Dipropionate in Descaled Skin of Adults With Chronic Plaque Psoriasis Over a 21-day Treatment Period|
|Actual Study Start Date :||April 15, 2019|
|Actual Primary Completion Date :||October 29, 2019|
|Actual Study Completion Date :||October 29, 2019|
Experimental: Microarray patch A
21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use
Drug: Microarray patch A
Experimental: Microarray patch B
21 day treatment, 3 times weekly, 9 applications in total, transdermal patch for cutaneous use
Drug: Microarray patch B
Placebo Comparator: Vehicle
21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use, no active substance
Microarray patch vehicle
Active Comparator: Daivobet
21 day treatment, paused on day 7, day 14 and day 21, Cutaneous use
- 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. [ Time Frame: From baseline up to EoT (Day 22) ]RBC, WBC, haemoglobin, haematocrit, platelets, white cell differentials; measured in SI units.
- Change from baseline to Day 22 (EoT) in clinical chemistry parameters. [ Time Frame: From baseline to EoT (Day 22) ]Sodium, potassium, BUN, glucose, AST, ALT, gamma GT, AP, calcium, phosphate, albumin, total cholesterol, LDH, total protein, creatinine, total bilirubin; measured in SI units.
- Change from baseline to Day 22 (EoT) in urinalysis parameters, single parameters only to be listed if deviation from usual urine dip test. [ Time Frame: From baseline to EoT (Day 22) ]E.g., leukocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin, measured in SI units.
- Number of subjects with abnormal clinically significant findings of physical examination at Day 22 (EoT). [ Time Frame: EoT (Day 22) ]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 22 (EoT) in systolic and diastolic blood pressure. [ Time Frame: From baseline to EoT (Day 22) ]Measured in mmHg.
- Change from baseline to Day 22 (EoT) in pulse. [ Time Frame: From baseline to EoT (Day 22) ]Measured in beats per minute.
- Frequency counts of overall tolerability assessment of skin reactions at Day 8, Day 15, Day 22, Day 36 and Day 50. [ Time Frame: From baseline up to trial end (Day 50) ](Assessment performed by an investigator using a 4-point score ['0 = very good', '1 = good', '2 = moderate', '3 = poor']).
- Change from baseline (pre-dose at Day 1) to Day 22 (EoT) in psoriatic infiltrate thickness. [ Time Frame: EoT (Day 22) ](Assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography; measured in µm).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898583
|LEO Pharma investigational site|
|Berlin, Germany, 10783|
|LEO Pharma investigational site|
|Hamburg, Germany, 20098|
|Study Director:||Medical Expert||LEO Pharma|