Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Short-term response
研究概览
简要总结
Piezoelectric drived microneedling treats refractory skin disorders using hollow microneedles assisted by ultrasound. Mechanically, the injection of medicine by hollow microneedling could makes the distribution of medicine more evenly. And the addition of ultrasound technique improves the effectiveness of microneedling. Investigators plan to conduct a pilot study to investigate the efficacy of using piezoelectric drived microneedles in treating refractory skin diseases.
详细描述
Piezoelectric drived microneedling treats refractory skin disorders using hollow microneedles assisted by ultrasound. Mechanically, the injection of medicine by hollow microneedling could makes the distribution of medicine more evenly. And the addition of ultrasound technique improves the effectiveness of microneedling. Investigators plan to conduct a pilot study to investigate the efficacy of using piezoelectric drived microneedles in treating refractory skin diseases. Investigators accept participants of hypertrophic scar, keloid and warts. For participants who are not candidates for traditional surgery, investigators will consider to accept carefully.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 16 years
- •Diagnosed by 2 or more professional dermatologists
- •Willing to underwent a new treatment modality
- •Follow up is easy to conduct
排除标准
- •Poor general condition
- •Bleeding tendency
- •Allergy to drug
研究组 & 干预措施
Traditional injection
Intralesional injection of drug by traditional injection needle. This is the traditional approach for drug delivery recommended by international guidelines for each skin diseases.
干预措施: Triamcinolone acetonide(scar)/5-ALA(others) (Drug)
Piezoelectric drived microneedling
Intralesional injection of drug by piezoelectric drived microneedles.
干预措施: Piezoelectric drived microneedling (Procedure)
Piezoelectric drived microneedling
Intralesional injection of drug by piezoelectric drived microneedles.
干预措施: 5-ALA (a photosensitizer for photodynamic therapy). (Drug)
结局指标
主要结局
Short-term response
时间窗: 1 week after treatment
This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully.
Long-term response
时间窗: 1 month after treatment
This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully.
次要结局
- Pain score during treatment(Immediately)
- POSAS(The Patient and Observer Scar Assessment Scale) score(1 month after treatment)