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

NCT ID: NCT01743118

Last Updated: 2013-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-07-31

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.

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Psoriasis Plaque Test

SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment

Group Type: EXPERIMENTAL

SPS4251 Ointment

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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).

Interventions

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)

Intervention Type: 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)

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

calcipotriol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bioskin GmbH

INDUSTRY

Sponsor Role: collaborator

Circassia Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bioskin

Berlin, , Germany

Bioskin

Hamburg, , Germany

Countries

Germany

Other Identifiers

SP001

Identifier Type: -

Identifier Source: org_study_id