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Trial record 41 of 272 for:    Betamethasone

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 : Recruiting
First Posted : April 2, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: Microarray patch A Drug: Microarray patch B Drug: Placebo Drug: Daivobet Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
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
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019


Arm Intervention/treatment
Experimental: Microarray patch A
21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use
Drug: Microarray patch A
Microarray patch
Other Names:
  • Calcipotriol
  • Betamethasone dipropionate

Experimental: Microarray patch B
21 day treatment, 3 times weekly, 9 applications in total, transdermal patch for cutaneous use
Drug: Microarray patch B
Microarray patch
Other Names:
  • Calcipotriol
  • Betamethasone dipropionate

Placebo Comparator: Vehicle
21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use, no active substance
Drug: Placebo
Microarray patch vehicle

Active Comparator: Daivobet
21 day treatment, paused on day 7, day 14 and day 21, Cutaneous use
Drug: Daivobet
Daivobet Gel
Other Names:
  • Calcipotriol
  • Betamethasone dipropionate




Primary Outcome Measures :
  1. Overall number of treatment-emergent adverse events. [ Time Frame: First IMP application up to trial end (Day 50) ]
  2. Number of treatment-emergent application site reactions, by treatment [ Time Frame: First IMP application up to trial end (Day 50) ]
  3. 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.

  4. 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.

  5. 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.

  6. 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'.

  7. Change from baseline to Day 22 (EoT) in systolic and diastolic blood pressure. [ Time Frame: From baseline to EoT (Day 22) ]
    Measured in mmHg.

  8. Change from baseline to Day 22 (EoT) in pulse. [ Time Frame: From baseline to EoT (Day 22) ]
    Measured in beats per minute.

  9. 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']).


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: LEO Pharma A/S (+1) 877-557-1168 disclosure@leo-pharma.com

Locations
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Germany
LEO Pharma investigational site Recruiting
Hamburg, Germany
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical Expert LEO Pharma

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03898583     History of Changes
Other Study ID Numbers: LP0120-1391
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcipotriene
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents