A split-face comparative study assessing the efficacy of microneedling with Tranexamic acid vs microneedling with Vitamin C in the treatment of melasma.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in MASI score
研究概览
简要总结
30 patients who fit the inclusion and exclusion criteria will be enrolled in the study after obtaining informed consent. A detailed history taking, examination, clinical photographs and MASI ( Melasma Area Severity Index ) score calculation will be done for all the patients prior to starting the intervention. Intervention will be done at 0,2,4, and 6 weeks and patient will be assessed at 2,4,6, and 8 weeks. Initially, patients face will be cleansed and topical anaesthetic (PRILOX cream ) will be applied for 45 minutes. Intervention will be in the form of application of Tranexamic acid ( 50mg in 2 ml ) over the right side of the face using sterile gauze, and 20% vitamin C serum ( 2ml ) over the left side of the face, following which1.5mm depth and 0.25mm width derma roller will be used to perform micro needling procedure on both sides. Patient will be observed for 30minutes post procedure for any side effects. Cumulative assessment of MASI score will be done at 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females aged 18 years and above with Melasma over bilateral sides of the face.
排除标准
- •Male gender.
- •Pregnant women, breastfeeding mothers.
- •History of use of oral contraceptive pills or hormone replacement therapy in the past 12 months or during the study.
- •History of coagulation disorders and thrombotic problems.
- •History of use of topical depigmenting agents within the last 60 days of the study.
- •Presence of active infection over the face.
- •Presence of keloidal tendency.
结局指标
主要结局
Reduction in MASI score
时间窗: 2, 4, 6 , 8 weeks
次要结局
- Patient satisfaction(2 , 4, 6 ,8 weeks)
研究者
Varsha Reddy Parupati
Sri Ramachandra Institute for Higher Education and Research