Antipsoriatic Effect of a Topical Formulation for the Treatment of Psoriasis Vulgaris

Study Overview
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Brief Summary
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The current most important topical treatments for psoriasis are vitamin D3 analogues and/or corticosteroids. The possibility of another effective treatment for psoriasis could be based on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel. The aim of the clinical trial is to evaluate the safety, tolerability and anti-psoriatic efficacy of topical SPS4251 formulations in comparison to placebo and to a marketed topical Vitamin-D analogue ointment in a psoriasis plaque test.

Official Title
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Phase Ib, Two-centre, Randomised, Observer-blind, Placebo- and Comparator Controlled Trial to Evaluate the Safety, Tolerability and Antipsoriatic Efficacy of Three Strengths of a Topical SPS4251 Formulation in a Psoriasis Plaque Test

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: SPS4251 Ointment
* Drug: Placebo
* Drug: Daivonex® ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men aged 18 years or older subjects with mild to moderate psoriasis vulgaris in a chronic stable phase subject with up to three stable plaques with an area sufficient for five treatment fields Plaques to be treated should have a comparable thickness of the Echo Lucent Band of at least 200 µm Exclusion Criteria: Subjects with guttate psoriasis, punctate psoriasis, erythrodermic psoriasis, psoriatic arthropathy and pustular psoriasis Local treatment with antipsoriatics in the 4 weeks preceding and/or during the trial, and any topical antipsoriatic treatment on the plaques to be treated in this trial in the 8 weeks before first treatment and/or during the trial Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids in the three months before first treatment and during the trial; Treatment with systemic medications or medications acting locally which might have countered or influenced the trial aim Contraindications according to summary of product characteristics of Daivonex® Ointment; UV-therapy within four weeks before first treatment and during the trial Symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before baseline visit and during the trial Any history of cardiovascular disease Any evidence of ECG abnormality on screening ECG Close affiliation with the Investigator (e.g. a close relative) or persons working at bioskin GmbH or subject is an employee of the Sponsor; Subject is institutionalized because of legal or regulatory order.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psoriasis Plaque Test<br>SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment | Drug: SPS4251 Ointment<br>* Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments)<br>Drug: Placebo<br>* Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments)<br>Drug: Daivonex® ointment<br>* Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments).<br>* Other names: calcipotriol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate |  | Up to Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of anti-psoriatic efficacy by clinical assessment |  | Up to day 12 | 
| Number of subjects with Adverse Events |  | Up to day 12 |