Randomized, Controlled, Double-blind Study of Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Change from Baseline mMASI Score at week 12
研究概览
简要总结
This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.
详细描述
Hydroquinone (HQ) is considered the gold standard depigmenting agent for melasma, nevertheless, many patients are recalcitrant to this treatment.
Recent studies have shown that tranexamic acid, a plasmin inhibitor, can prevent UV-induced pigmentation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •moderate melasma (subject with mMASI score of 5 to 7.9),
- •severe melasma (subject with mMASI score ≥ 8),
- •willing to follow up for 6 months.
排除标准
- •pregnant women,
- •nursing women,
- •women on exogenous hormones
- •current treatment with blood thinners,
- •had a history of thrombosis,
- •had an abnormal kidney function,
- •use of topical hydroquinone within 3 months of study enrollment,
- •use of topical steroids, vitamin A analogs, chemical peels within 1 month of study
研究组 & 干预措施
Study
Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
干预措施: Tranexamic Acid Oral Product (Drug)
Study
Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
干预措施: Hydroquinone 4% Cream (Drug)
Study
Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
干预措施: Sunscreen (Other)
Control
Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
干预措施: Hydroquinone 4% Cream (Drug)
Control
Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
干预措施: Sunscreen (Other)
Control
Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
干预措施: Placebo (Device)
结局指标
主要结局
Change from Baseline mMASI Score at week 12
时间窗: Baseline, week 2, 12, 24
modified Melasma Area and Severity Index (mMASI) score was performed by rating darkness and area of involvement of 4 areas of the face (forehead, right malar, left malar, chin) Scoring system: A, Area of involvement rated 0 to 6: 0 indicates absent; 1, \<10%; 2, 10% to 29%; 3, 30% to 49%; 4, 50% to 69%; 5, 70% to 89%; 6, 90% to 100%. D, Darkness rated 0 to 4: 0 indicates absent; 1, slight; 2, mild; 3, marked; 4, severe. b Total mMASI score range is 0 to 24 and calculated by adding scores for 4 areas of the face. Forehead (0.3xAxD) + Right Malar (0.3xAxD) + Left Malar (0.3xAxD) + Chin (0.1xAxD)
次要结局
- Melanin index(Baseline, week 2, 12, 24)
研究者
Nahla Shihab
Principal Investigator
Fakultas Kedokteran Universitas Indonesia