Efficacy and Safety of Using Combination of 755-nm Picosecond Alexandrite Laser and 2% Hydroquinone Compared With 2% Hydroquinone Alone for the Treatment of Melasma: a Randomized Split-face Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Melanin index measured by Mexameter® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
研究概览
简要总结
This study aims to assess the efficacy and safety of using combination of 755-nm picosecond alexandrite laser and 2% hydroquinone compared with 2% hydroquinone alone for the treatment of melasma: A randomized split-face controlled trial
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both male and female age 18-60 years
- •Melasma on both cheeks - epidermal or mixed type
- •Fitzpatrick Skin type III-V
排除标准
- •History of retinoid or other keratolytic drugs used within 6 months before enrolled
- •History of keloid
- •photosensitivity
- •Immunocompromised host
研究组 & 干预措施
split face - left side
干预措施: 755-nm picosecond alexandrite laser with topical 2% hydroquinone (Device)
split face - right side
干预措施: topical 2% hydroquinone (Drug)
结局指标
主要结局
Melanin index measured by Mexameter® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
时间窗: 6 months
measuring in au
Average melanin measured by Antera3D® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
时间窗: 6 months
measuring in au
Modified melasma area and severity index score(mMASI) - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma of using combination of 755-nm picosecond alexandrite laser and 2% hydroquinone
时间窗: 6 months
score range 0-24
Patient satisfaction quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
时间窗: 6 months
score 0 -100%
Physician evaluation quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
时间窗: 6 months
score 0 -100%
次要结局
- Safety of using combination of 755-nm picosecond alexandrite laser(6 months)
- Safety of using 2% hydroquinone(6 months)
研究者
Woraphong Manuskiatti, M.D.
Professor
Mahidol University