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

Phase 1

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: SPS4251 Ointment; Drug: Placebo; Drug: Daivonex® ointment

• Registration Number: NCT01743118
• Lead Sponsor: Circassia Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Study Start: 2013-03
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-16
• Last Update Posted: 2013-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psoriasis Plaque Test	SPS4251 Ointment	SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment
Psoriasis Plaque Test	Placebo	SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment
Psoriasis Plaque Test	Daivonex® ointment	SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment

Primary Outcome Measures

Name	Time	Method
Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate	Up to Day 12

Secondary Outcome Measures

Name	Time	Method
Evaluation of anti-psoriatic efficacy by clinical assessment	Up to day 12
Number of subjects with Adverse Events	Up to day 12

Trial Locations

Locations (1)

Bioskin; 🇩🇪 Hamburg, Germany