Efficacy of Microneedle Patch on Topical Ointment Treatment of Psoriasis
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The improvement of psoriasis
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of microneedle patch on the psoriatic plaques.
详细描述
As a novel minimally invasive approach, microneedle-mediated transdermal drug delivery has received increased attention. Microneedle patch effectively penetrates the skin barrier of the stratum corneum and create efficient pathways for the delivery of drugs.
A randomized controlled trial based on split-body was planned to evaluate the efficacy of enhanced transdermal delivery of topical agent by hyaluronic acid (HA)-fabricated microneedle patch in psoriatic plaques. Six psoriatic plaques in a patient will be randomized to either microneedle HA patch, patch, or control groups. Patch group is planned for rule out the occlusion effect of patches. All lesions will be treated with topical agent and patches daily for 2-week period. The severity of psoriasis will be grated with modified PASI score and the clinical improvement will be assessed as % from baseline every week. Overall 20 patients with 120 psoriatic plaques will be enrolled.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: older than 19
- •A patient with psoriasis
- •A patient with symmetrical psoriatic lesions
- •A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
- •A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
排除标准
- •Age: lower than 20
- •A pregnant or lactating patient
- •A patient who cannot understand the study or who does not sign the informed consent
结局指标
主要结局
The improvement of psoriasis
时间窗: Baseline, 1 week, 2 weeks
The severity of psoriasis will be graded with modified PASI score, and the improvement will be assessed as % from baseline by using a computer program.
次要结局
- The adverse effects of microneedle patch(Baseline, 1 week, 2 weeks)
研究者
Jung Min Bae
Clinical Assistant Professor
The Catholic University of Korea