Clinical trial NCT01743118: Antipsoriatic Effect of a Topical Formulation for the Treatment of Psoriasis Vulgaris
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis Vulgaris
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Bioskin GmbH
First posted: 2012-12-06
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate
timeFrame: Up to Day 12
Secondary outcomes:
measure: Evaluation of anti-psoriatic efficacy by clinical assessment
timeFrame: Up to day 12
measure: Number of subjects with Adverse Events
timeFrame: Up to day 12
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Bioskin
city: Hamburg
country: Germany
facility: Bioskin
Study officials:
References: