RF Microneedle Therapy Maintains the Treatment Effect of Melasma: A 32-week, Prospective, Randomized Split-face Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change of lightness value
研究概览
简要总结
Melasma relapse is almost common after discontinuation of conventional treatment. Recent studies have suggested that photoaging dermis is main pathomechanism of melasma emphasizing stromal targeting therapy. Therefore, we investigated maintenance effect of microneedle radiofrequency (RF) for melasma treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult more than 19 years old
- •Melasma clinically diagnosed by three dermatologists
排除标准
- •Aesthetic medical procedures in three months prior to the study
- •Use of topical depigmenting agents in three months prior to the study
- •Pregnant or lactating
研究组 & 干预措施
Conventional therapy with RF microneedle
Half face Oral tranexamic acid combined with triple combination cream with RF microneedle
干预措施: RF Microneedle (Device)
Conventional therapy with RF microneedle
Half face Oral tranexamic acid combined with triple combination cream with RF microneedle
干预措施: Combination cream (Drug)
Conventional therapy
Half face Oral tranexamic acid combined with triple combination cream
干预措施: Combination cream (Drug)
结局指标
主要结局
Change of lightness value
时间窗: Every 1 month up to 8 months
Change of lightness value by a chromometer
Change of modified melasma area severity index score
时间窗: Every 1 month up to 8 months
Change of modified melasma area severity index score
次要结局
未报告次要终点
研究者
Jin Cheol Kim
Principal Investigator, Clinical Fellow
Ajou University School of Medicine