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.

September 10, 2020 updated by: LEO Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10783
        • LEO Pharma Investigational Site
      • Hamburg, Germany, 20098
        • LEO Pharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall number of treatment-emergent adverse events.
Time Frame: First IMP application up to trial end (Day 50)
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)
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.
From baseline up to EoT (Day 22)
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.
From baseline to EoT (Day 22)
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.
From baseline to EoT (Day 22)
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'.
EoT (Day 22)
Change from baseline to Day 22 (EoT) in systolic and diastolic blood pressure.
Time Frame: From baseline to EoT (Day 22)
Measured in mmHg.
From baseline to EoT (Day 22)
Change from baseline to Day 22 (EoT) in pulse.
Time Frame: From baseline to EoT (Day 22)
Measured in beats per minute.
From baseline to EoT (Day 22)
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']).
From baseline up to trial end (Day 50)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
EoT (Day 22)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

October 29, 2019

Study Completion (Actual)

October 29, 2019

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0120-1391

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriasis Vulgaris

Clinical Trials on Microarray patch A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe