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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Circassia Limited
• Collaborator: Bioskin GmbH
• Treatments: Calcipotriene

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.