Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Modified Melasma Area and Severity Index (mMASI) score
研究概览
简要总结
A double-blind, randomized, split-face controlled trial of 34 female patients with melasma was conducted. All subject were randomized to receive either intradermal tranexamic acid or placebo injection on the right or the left side of their face.
详细描述
All subject were randomized to receive either 10 mg of intradermal tranexamic acid or placebo injection on the right or the left side of their face.
The primary outcome was improvement of melasma lesions assessed by modified Melasma Area and Severity Index (mMASI) score and mexameter examination which includes Melanin Index (MI) and Erythema Index (EI).
Measurements were done at baseline and every two weeks for twelve weeks. Additionally, side effects of therapy and subjects' satisfactory assessment with patient global assessment (PtGA) were also documented.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The allocation sequence was generated with a computer by an analyst. The allocation sequence was concealed from the investigators, care provider, outcomes assessor, and subjects.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged 18 to 60 years old
- •Fitzpatrick skin type IV - V
- •diagnosed with melasma
排除标准
- •pregnancy and breastfeeding
- •use of oral contraceptives within six months
- •use of topical or systemic melasma therapy within two weeks
- •history of superficial peeling within four weeks
- •history of dermabrasion within six months
- •use of photosensitizer drugs
- •history of thrombosis or currently using antithrombotic or anticoagulant drugs
- •history of TA allergy
- •experiencing any COVID-19 symptoms
研究组 & 干预措施
Tranexamic acid
The intervention was 1 ml of 10 mg/ml of tranexamic acid solution which was given intradermally.
干预措施: Tranexamic acid injection (Drug)
Placebo
The placebo was 1 ml of 0.9% normal saline which was given intradermally.
干预措施: Injection Water (Drug)
结局指标
主要结局
Modified Melasma Area and Severity Index (mMASI) score
时间窗: 12 weeks
Reduction of mMASI score
Melanin Index
时间窗: 12 weeks
Reduction of melanin index
Erythema Index
时间窗: 12 weeks
Reduction of erythema index
次要结局
- Side effects(12 weeks)
- Subject's satisfaction(12 weeks)
研究者
Vashty Amanda Hosfiar
MD
Indonesia University