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

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743118
• Other study ID #: SP001
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2012
• Last updated: July 16, 2013
• Start date: March 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

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)
• 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)
• 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).

Locations

Country	Name	City	State
Germany	Bioskin	Berlin
Germany	Bioskin	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Circassia Limited	Bioskin GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate		Up to Day 12	No
Secondary	Evaluation of anti-psoriatic efficacy by clinical assessment		Up to day 12	No
Secondary	Number of subjects with Adverse Events		Up to day 12	Yes