A Split-face Comparison of Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Vitamin C vs Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Intradermal Tranexamic Acid Injection for Melasma:a Single Blinded, Randomised Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Melasma area severity index (MASI)
研究概览
简要总结
BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid both showed efficacy on the treatment of melasma. However, no combination therapy of both be reported.
OBJECTIVES: To compare the efficacy of low influence Q switched 1064nm Nd:YAG laser and low influence Q switched 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection for melasma.
详细描述
METHODS: Twenty patients with melasma were included in a randomized controlled observer-blinded study with split-face design. Each side of the face was randomly allocated to either six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz) or low influence 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection.Complication Improvement of melasma was assessed by Melasma area severity index (MASI),physician's global assessment (PhGA), MELASQOL scale, patient's global assessment (PGA), and patient's satisfaction at baseline,6th week,10th week after first treatment and 3 months, and 6 months after last treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients > 20 years old with refractory melasma to topical treatment
排除标准
- •History of keloid, active eczema, active acne in the face, history of facial eczema, photosensitivity, use of isotretinoin in the past 6 months, pregnancy, and high exposure to sunlight or UV light (UVA or UVB)
研究组 & 干预措施
Nd-YAG
ND-YAG only
干预措施: Nd-YAG (Device)
Nd-YAG and intradermal tranexamic acid
Nd-YAG combine with intradermal tranexamic acid
干预措施: intradermal tranexamic acid (Procedure)
Nd-YAG and intradermal tranexamic acid
Nd-YAG combine with intradermal tranexamic acid
干预措施: Nd-YAG (Device)
结局指标
主要结局
Melasma area severity index (MASI)
时间窗: 6 months after last treatment
次要结局
- Quality of life by MELASQOL scale(6th week,10th week after first treatment and 3 months, and 6 months after last treatment)
- Improvement by patient's global assessment (PGA),(6th week,10th week after first treatment and 3 months, and 6 months after last treatment)
- Patient's satisfaction (VAS)(6th week,10th week after first treatment and 3 months, and 6 months after last treatment)
- Improvement by physician's global assessment (PhGA)(6th week,10th week after first treatment and 3 months, and 6 months after last treatment)
研究者
Huang Yu Chen
Attending physician of Dermatology Department
Taipei Medical University WanFang Hospital