NCT03686787Unknown4 期
The Efficacy of Oral Tranexamic Acid and a 1927 nm Diode Laser in Patients With Melasma. A Prospective Randomized Split Face Study
Laser and Skin Surgery Center of New York3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Change of mMASI (Modified Melasma Area and Severity Index)
研究概览
简要总结
Tranexamic acid and 1927 diode laser non-ablative fractionated laser for the treatment of Melasma.
详细描述
Seeking healthy non-smoking male and female volunteers of all skin types of age 18 to 50 with moderate melasma or severe melasma. Participants will receive up to 5 monthly laser treatments to half the face and need to take a pill twice a day for 4 months. Follow up visits are required 1 month, 3 months and 6 months after the final treatment. Compensation of up to $150 will be provided based on completed visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 50 Skin types I through VI (all skin types) Moderate or severe melasma
排除标准
- •Pregnant or nursing women Current use of hormonal birth control medication or any hormonal therapy Use of topical steroids within 1 month of study enrollment Use of topical hydroquinone within 3 months of study enrollment History of laser or dermabrasion to the face within 6 months of study enrollment Regular use of tanning parlors Occupation involving primarily outdoor activities Current treatment with blood thinning medications History of thrombosis or thrombophilia History of thromboembolic disease, such as deep vein thrombosis, pulmonary embolism and/or cerebral thrombosis Family history of thromboembolic disease History of stroke History of >2 spontaneous abortions History of kidney dysfunction History of cancer Smoking Significant cardiovascular or respiratory disease (end-stage congestive heart failure or chronic obstructive pulmonary disease) History of subarachnoid hemorrhage History of acquired disturbances of color vision Known allergy to tranexamic acid As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
结局指标
主要结局
Change of mMASI (Modified Melasma Area and Severity Index)
时间窗: 16 weeks
The difference between mMASI at week 0 and mMASI at week 16
次要结局
未报告次要终点
研究者
研究点 (3)
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