The CLINICAL And MOLECULAR EFFECTS Of An INSULIN SENSITIZING DRUG: 'PIOGLITAZONE'On PSORIASIS TREATMENT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Treatment success detected as clinical improvement of skin condition
研究概览
简要总结
The study will assess the effectiveness of Pioglitazone on cellular and clinical levels in terms of improvement of both skin and systemic manifestations of psoriasis.
The investigators assume that pioglitazone (one of thiazolidinediones readily available in Egypt), can regulate keratinocytes' disordered proliferation observed in psoriasis, in addition to improving the insulin resistance in peripheral tissues observed in many psoriatic patients and causing metabolic syndrome. This will allow to give a safer therapy than the available ones for psoriasis and to treat the patient in a more global perspective.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and less than 65 years.
- •Plaque psoriasis vulgaris ≥ 10% (apart from palmoplantar psoriasis which will be included).
排除标准
- •Age less than 18 years and more than 65 years
- •Mild psoriasis less than 10% body surface area
- •Erythrodermic or pustular psoriasis
- •Liver disease, cardiac disease (suspected from history or ECG), or any other major medical disorder detected by history.
- •Pregnant and lactating females.
研究组 & 干预措施
actozone A
Pioglitazone 30 mg tablets daily
干预措施: actozone A (Drug)
actozone B
placebo
干预措施: actozone B (Drug)
结局指标
主要结局
Treatment success detected as clinical improvement of skin condition
时间窗: 10 weeks
PASI improvement by at least 50% from baseline before treatment(Psoriasis Area and Severity Index)= PASI-50
次要结局
- Fasting serum insulin reduction from baseline before treatment(10 weeks)
- C-reactive protein titre reduction from baseline value before treatment(10 weeks)