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.

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898583
• Other study ID #: LP0120-1391
• Status: Completed
• Phase: Phase 1
• Start date: April 15, 2019
• Est. completion date: October 29, 2019

Study information

• Verified date: September 2020
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess safety, tolerability and pharmacodynamics effect of treatment with microarray patches containing calcipotriol and betamethasone dipropionate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Microarray patch A
Microarray patch
• Microarray patch B
Microarray patch
• Placebo
Microarray patch vehicle
• Daivobet
Daivobet Gel

Locations

Country	Name	City	State
Germany	LEO Pharma investigational site	Berlin
Germany	LEO Pharma investigational site	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall number of treatment-emergent adverse events.		First IMP application up to trial end (Day 50)
Primary	Number of treatment-emergent application site reactions, by treatment		First IMP application up to trial end (Day 50)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Change from baseline to Day 22 (EoT) in systolic and diastolic blood pressure.	Measured in mmHg.	From baseline to EoT (Day 22)
Primary	Change from baseline to Day 22 (EoT) in pulse.	Measured in beats per minute.	From baseline to EoT (Day 22)
Primary	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']).	From baseline up to trial end (Day 50)
Secondary	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)