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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
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Tracking Information
First Submitted Date  ICMJE March 29, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date September 11, 2020
Actual Study Start Date  ICMJE April 15, 2019
Actual Primary Completion Date October 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • 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']).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary To assess safety, tolerability and pharmacodynamics effect of treatment with microarray patches containing calcipotriol and betamethasone dipropionate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Intra-individual comparison of all treatments
Masking: Single (Investigator)
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.
Primary Purpose: Treatment
Condition  ICMJE Psoriasis Vulgaris
Intervention  ICMJE
  • Drug: Microarray patch A
    Microarray patch
    Other Names:
    • Calcipotriol
    • Betamethasone dipropionate
  • Drug: Microarray patch B
    Microarray patch
    Other Names:
    • Calcipotriol
    • Betamethasone dipropionate
  • Drug: Placebo
    Microarray patch vehicle
  • Drug: Daivobet
    Daivobet Gel
    Other Names:
    • Calcipotriol
    • Betamethasone dipropionate
Study Arms  ICMJE
  • Experimental: Microarray patch A
    21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use
    Intervention: Drug: Microarray patch A
  • Experimental: Microarray patch B
    21 day treatment, 3 times weekly, 9 applications in total, transdermal patch for cutaneous use
    Intervention: Drug: Microarray patch B
  • Placebo Comparator: Vehicle
    21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use, no active substance
    Intervention: Drug: Placebo
  • Active Comparator: Daivobet
    21 day treatment, paused on day 7, day 14 and day 21, Cutaneous use
    Intervention: Drug: Daivobet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 29, 2019
Actual Primary Completion Date October 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03898583
Other Study ID Numbers  ICMJE LP0120-1391
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Expert LEO Pharma
PRS Account LEO Pharma
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP