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

Circassia Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Psoriasis Vulgaris

Treatments

Drug: SPS4251 Ointment

Drug: Daivonex® ointment

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01743118

SP001

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.