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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. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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.

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

NCT03898583•LEO Pharma

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.

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.
+5 more criteria

Locations (2)

LEO Pharma investigational site

Berlin, Germany

LEO Pharma investigational site

Hamburg, Germany

Key Dates

Start Date

April 15, 2019

Primary Completion Date

October 29, 2019

Completion Date

October 29, 2019

Last Updated

February 24, 2025

Enrollment

ACTUAL participants

Conditions

Psoriasis Vulgaris

Interventions

Microarray patch A

DRUG

Microarray patch B

DRUG

Placebo

DRUG

Daivobet

DRUG

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

NCT04080635

Psoriasis Vulgaris

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COMPLETEDPHASE4

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

NCT04340076

PsoriasisPsoriasis Vulgaris

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WITHDRAWNNA

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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.

Inclusion Criteria

Exclusion Criteria

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP

A Pilot Study to Explore the Role of Gut Flora in Psoriasis

The Mediterranean Diet and Time-Restricted Eating Dietary Interventions for Psoriasis Study