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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Psoriasis Plaque Test
SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment
干预措施: SPS4251 Ointment (Drug)
Psoriasis Plaque Test
SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment
干预措施: Placebo (Drug)
Psoriasis Plaque Test
SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment
干预措施: Daivonex® ointment (Drug)
结局指标
主要结局
Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate
时间窗: Up to Day 12
次要结局
- Evaluation of anti-psoriatic efficacy by clinical assessment(Up to day 12)
- Number of subjects with Adverse Events(Up to day 12)