Comparative Efficacy of Intralesional Tranexamic Acid and Platelets Rich Plasma in the Treatment of Melasma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Melasma severity index
研究概览
简要总结
ABSTRACT Objective: To study the efficacy while comparing Intralesional tranexamic acid Vs Platelets rich plasma (PRP) in treatment of Melasma.
Study design: Randomized-controlled trial (RCT). Study setting and duration: Dept of dermatology, CMH-Abbottabad, Nov-2022 /April-2023.
Methodology: The sample size of 60 patients 20 to 40 years were calculated by using Openepi App. The informed consent was taken. The patients were randomly allocated to two groups: Group A (30 patients injected with Intradermal Tranexamic acid (4mg/ml) and Group B (30 patients treated with PRP (1ml) intra-dermally, every fourth week for up to 12 weeks between both groups). The mMASI scale was used to evaluate all patients. The final evaluation was performed on the 24th week of follow-up. For analysis Statistical Package for the social sciences version-27 was used. To determine statistical significance a paired t-samples test with a p-value of < 0.05 was applied.
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20_40 years of age
- •suffering from melasma
排除标准
- •pregnancy
- •breastfeeding mothers
- •allergic to tranexamic acid
- •bleeding disorders
- •warts or facial eczema
研究组 & 干预措施
Intralesional tranexamic acid in the treatment of melasma
Group A 30 patients treated with Intradermal Tranexamic acid injection (4mg/ml) for preparation an insulin syringe was used with a volume of 1ml containing 0.04 ml of TXA and the reminder being normal saline to ensure 4mg preparation in each insulin syringe
干预措施: Tranexamic acid (Drug)
Intrlesional platelets rich plasma in the treatment of melasma
Group B 30 patients prescribed with PRP (1ml) intra-dermally PRP was obtained manually by a two-step procedure using a centrifuge machine. First spin was performed at 1500 RPM for 10 minutes. Second spin was performed at 4000 RPM for 10 minutes. Thus, obtaining a two-part plasma. Upper two third was platelet poor plasma and was discarded. Lower one third was platelets rich plasma. Before injection applying 0.1 ml calcium chloride was added for each 1 ml of PRP to activate the platelets. PRP was injected 1 ml by using 30 G needle (insulin syringe) in each cm2 of melasma.
干预措施: Platelets rich plasma (Drug)
结局指标
主要结局
Melasma severity index
时间窗: 24 weeks
Modified melasma area severity score is used to measure effectiveness of both drugs in treatment of melasma Score value ranges from 0-24 . 24 means melasma is more severe
次要结局
未报告次要终点
研究者
Dr sana aslam
Principal investigator
Combined Military Hospital Abbottabad