The Efficacy of Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores Compared to Intradermal Botulinum Toxin
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of microneedle patch with botulinum toxin for improving enlarged pores.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old and concerned about enlarged pores
- •Have pore size 0.3-0.6 mm
- •Have pore parameter in each other side of faces not different more than 5%
排除标准
- •Any neuromuscular condition
- •Pregnancy or breast feeding
- •History of allergy : Botulinum toxin, topical anesthesia
- •History of keloid or hypertrophic scar
- •History of coagulation or receiving medication that causes coagulation disorder
- •Using drugs that have interaction with Botulinum toxin
- •Using topical medication that improves enlarged pores in 1 month
- •Taking medication that improves enlarged pores in 1 month
- •Receiving the laser/treatment/chemical peeling in 6 months
研究组 & 干预措施
Microneedle patch with Botulinum toxin
Participants recieve microneedle path with 20 units Botulinum toxin at nose and cheek one side.
干预措施: Microneedle patch (Device)
Intradermal Botulinum toxin injection
Participants recieve intradermal 20 units Botulinum toxin injection at nose and cheek in other side.
干预措施: Intradermal injection (Device)
结局指标
主要结局
Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score
时间窗: Post-intervention, week 4 and week 16
the used pore scores, patients with visible pores took the score "1," and those with enlarged pores took "2." When black heads were embedded on facial pores the score was "3." The scores were assessed by 2 investigators who were blinded to the treatment used on each side.
次要结局
未报告次要终点
研究者
Chotip Jitudomtham
Chotip Jitudomtham
Dhurakij Pundit University