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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: SPS4251 Ointment; Drug: Placebo; Drug: Daivonex® ointment

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Bioskin
  • Hamburg, Germany
    • Bioskin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Psoriasis Plaque Test; SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment

Drug: SPS4251 Ointment; 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); Drug: Placebo; 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); Drug: Daivonex® ointment; 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).; Other Names: calcipotriol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Circassia Limited
• Collaborators: Bioskin GmbH

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: December 3, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): July 17, 2013
• Last Update Submitted That Met QC Criteria: July 16, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Calcipotriene
• Other Study ID Numbers: SP001