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.

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Psoriasis Vulgaris

Treatments: Drug: Placebo; Drug: Microarray patch A; Drug: Microarray patch B; Drug: Daivobet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03898583

LP0120-1391

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 4 patient groups, including a placebo group

Microarray patch A

Experimental group

Description:

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

Treatment:

Drug: Microarray patch A

Microarray patch B

Experimental group

Description:

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

Treatment:

Drug: Microarray patch B

Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Daivobet

Active Comparator group

Description:

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

Treatment:

Drug: Daivobet