Clinical trial NCT03898583: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2019-04-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Intra-individual comparison of all treatments
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Overall number of treatment-emergent adverse events.
timeFrame: First IMP application up to trial end (Day 50)
measure: Number of treatment-emergent application site reactions, by treatment
timeFrame: First IMP application up to trial end (Day 50)
measure: Change from baseline to Day 22 (EoT) in haematology parameters.
timeFrame: From baseline up to EoT (Day 22)
measure: Change from baseline to Day 22 (EoT) in clinical chemistry parameters.
timeFrame: From baseline to EoT (Day 22)
measure: Change from baseline to Day 22 (EoT) in urinalysis parameters, single parameters only to be listed if deviation from usual urine dip test.
timeFrame: From baseline to EoT (Day 22)
measure: Number of subjects with abnormal clinically significant findings of physical examination at Day 22 (EoT).
timeFrame: EoT (Day 22)
measure: Change from baseline to Day 22 (EoT) in systolic and diastolic blood pressure.
timeFrame: From baseline to EoT (Day 22)
measure: Change from baseline to Day 22 (EoT) in pulse.
timeFrame: From baseline to EoT (Day 22)
measure: Frequency counts of overall tolerability assessment of skin reactions at Day 8, Day 15, Day 22, Day 36 and Day 50.
timeFrame: From baseline up to trial end (Day 50)
Secondary outcomes:
measure: Change from baseline (pre-dose at Day 1) to Day 22 (EoT) in psoriatic infiltrate thickness.
timeFrame: EoT (Day 22)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: LEO Pharma investigational site
city: Hamburg
country: Germany
facility: LEO Pharma investigational site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: