Intrapatient Comparison Study of Efficacy of STA-21 Ointment on Psoriatic Skin Lesions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe)
研究概览
简要总结
The clinical assessment of patients with plaque-type psoriasis is performed by open, intrapatient comparison of 0.2% STA-21 with vehicle(Vaseline) alone within a 2 week period.
详细描述
Two discrete psoriatic lesions with a similar size (approximately coin-sized) and clinical severity are selected in each patient. Clinical assessment of psoriatic lesion severity is performed at the baseline and at 1 and 2 (end of treatment) using the scores of erythema, induration, scaling on a scale of 0-4 by two observers. Since STA-21 inhibits Stat3 activation, which is essential for disease activity of psoriasis, topical application of 0.2% STA-21 in Vaseline should improve psoriasis in two weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of plaque psoriasis for a minimum of 2 years.
- •In good general health, as evidenced by blood, renal function, and liver function tests conducted before commencing the study.
- •Patients of childbearing age who agreed to continue using birth control for the duration of the study.
- •Men or women between 20 and 80 years old.
排除标准
- •Chronic plaque psoriasis involving >40% of the body surface.
- •Pustular or generalized erythrodermic psoriasis.
- •Use of medications that might affect the psoriasis during the study
- •Systemic therapy for psoriasis within 60 d of baseline.
- •UV therapy within 21 d of baseline.
- •Topical therapy within 14 d of baseline.
- •Positive for HIV, hepatitis B, or hepatitis C.
- •Clinically significant laboratory abnormality in blood, renal function, or liver function.
- •Lactating, pregnant, or planning to become pregnant.
- •Participation in another clinical trial in the last 30 d.
- •Unwillingness to comply with the study protocol.
- •Any other condition that in the opinion of the investigators could compromise the study.
研究组 & 干预措施
Psoriasis therapy
干预措施: Topical application of STA-21 ointment for treatment of psoriasis (Drug)
结局指标
主要结局
Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe)
时间窗: 2 weeks
次要结局
未报告次要终点