NCT00816517已完成1 期
Pilot Study on the Safety and Efficacy of Botulinum Toxin Injections in the Treatment of Psoriasis Vulgaris.
适应症
干预措施
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
- psoriasis scoring scale
研究概览
简要总结
Psoriasis vulgaris is a chronic disease in which psoriatic plaques may appear on the knees, elbows, scalp and trunk. Evidence suggests the role of neurogenic inflammation in the pathogenesis of psoriasis. Botulinum toxin has been shown to have an effect on inhibiting neurogenic inflammation.
Recently, it was reported that patients who suffered from dystonia and had concomitant psoriasis, when treated with botulinum toxin for dystonia noted a dramatic improvement of their psoriatic lesions.
This pilot study will determine the safety and efficacy of botulinum toxin in the management of psoriasis vulgaris.
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
- None
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
- •Healthy subjects. Psoriasis vulgaris diagnosis made by a board certified dermatologist involving at least one area that has been intolerant or recalcitrant to at least two forms of recognized topical or systemic treatments in the past. In addition, the subject should have at least a score of 2 for keratoderma and erythema. Signed informed consent. Willing to adhere to protocol.
排除标准
- •Immunosuppressed patients, pregnant, secondary skin infections, phototherapy within 4 weeks of the botulinum toxin injection, exposure to any topical or systemic retinoid treatment with the last 12 months, volunteers taking chloroquine and hydroxychloroquine, volunteers on warfarin.
研究组 & 干预措施
botulinum toxin
Experimental
injection of botulinum toxin type A
干预措施: injection of botulinum toxin type A. (Biological)
结局指标
主要结局
psoriasis scoring scale
时间窗: baseline and 3months
次要结局
- 3mm skin biopsy.(baseline and at 3 months.)
研究者
研究点 (1)
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