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.

NCT ID: NCT03898583

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2019-10-29

Brief Summary

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

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Microarray patch A

21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use

Group Type: EXPERIMENTAL

Microarray patch A

Intervention Type: DRUG

Microarray patch

Microarray patch B

21 day treatment, 3 times weekly, 9 applications in total, transdermal patch for cutaneous use

Group Type: EXPERIMENTAL

Microarray patch B

Intervention Type: DRUG

Microarray patch

Vehicle

21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use, no active substance

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Microarray patch vehicle

Daivobet

21 day treatment, paused on day 7, day 14 and day 21, Cutaneous use

Group Type: ACTIVE_COMPARATOR

Daivobet

Intervention Type: DRUG

Daivobet Gel

Interventions

Microarray patch A

Microarray patch

Intervention Type: DRUG

Microarray patch B

Microarray patch

Intervention Type: DRUG

Placebo

Microarray patch vehicle

Intervention Type: DRUG

Daivobet

Daivobet Gel

Intervention Type: DRUG

Other Intervention Names

Calcipotriol; Betamethasone dipropionate; Calcipotriol; Betamethasone dipropionate; Calcipotriol; Betamethasone dipropionate

Eligibility Criteria

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

LEO Pharma investigational site

Berlin, , Germany

LEO Pharma investigational site

Hamburg, , Germany

Countries

Germany

Other Identifiers

LP0120-1391

Identifier Type: -

Identifier Source: org_study_id