A Single-Center, Randomized, Observer Blind, Vehicle- and Comparator-controlled Trial to Evaluate the Antipsoriatic Efficacy and Safety of Topical Formulations of C-82 in a Psoriasis Plaque Test
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate
研究概览
简要总结
Evaluate the effects of topical C-82 in a psoriasis plaque test.
详细描述
The primary objective of this trial is to evaluate antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate using 20 MHz sonography. To gain additional information about possible efficacy the change of the test fields compared to untreated plaque will be clinically assessed by visual scoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •mild to moderate chronic stable plaque type psoriasis
- •plaques thickness of at least 200 µm
- •lesion(s) on the trunk or extremities (excluding palms/soles)
- •skin must be without disease findings
排除标准
- •other skin disease
- •psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis
- •treatment with any locally acting medications (including anti-psoriatics like vitamin D analogues, dithranol) within 2 weeks preceding and during the trial
- •treatment with any systemic medications (including anti-psoriatics like corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (e.g. beta-blocker, anti-malarial drugs, lithium) or phototherapy/PUVA within 4 weeks preceding and during the trial
- •treatment with any biologics within 3 months preceding and during the trial
- •known allergic reactions, irritations or sensitivity to the active ingredients or other components of the investigational products (e.g. Carbomere 940, propylene glycol)
- •drug or alcohol abuse
- •symptoms of a clinically significant illness within 4 preceding and during the trial
- •participation another clinical trial within 4 weeks of this clinical trial
研究组 & 干预措施
IMP 1
C-82 Topical Gel, 1%
干预措施: C-82 Topical Gel, 1% (Drug)
IMP 2
C-82 Topical Gel, placebo
干预措施: C-82 Topical Gel, Placebo (Drug)
IMP 3
Daivonex cream
干预措施: Daivonex cream (Drug)
IMP 4
Diprosis gel
干预措施: Diprosis gel (Drug)
结局指标
主要结局
antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate
时间窗: day 12
次要结局
- antipsoriatic efficacy compared to control by clinical assessment using a 5-point score.(Day 8 & Day 12)
- number of subjects with adverse events(daily through Day 12)