Photoaging Reversing After Picosecond Laser With Diffractive Focus Lens Assessed by Cellular Resolution Optical Coherent Tomography in Asian Patient With Melasma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Improvement of MASI score
研究概览
简要总结
Background Melasma is a commonly acquired hypermelanosis that affects facial sun exposed areas, most commonly in Asians and other darker skin type females. Recent evidence has demonstrated melasma to be a photoaging disorder. The histological findings of melasma are similar to photoaging and include solar elastosis, increased mast cells and sebaceous glands, as well as increased vascularization. Pendulous active melanocytes with weakened basal membranes, and changes in nuclear morphology and chromatin texture of adjacent basal keratinocytes also seemed to be a characteristic feature of melasma.
Objectives:
To compare the difference of photoaging features of melasma skin and normal skin by optical coherence tomography (ApolloVue® S100 Image System, a 510(K) class II medical device) and reversal of photoaing features by 755nm picosecond alexandrite laser with diffractive lens.
Methodology:
We enroll 20 adults with facial melasma. The patients received 755nm picosecond alexandrite laser with diffractive lens array over whole face at W0, W4, and W8. Evaluation with VISIA, optical coherence tomography, Cutometer MPA580 at W4, W8, W12. All the patients will be instructed with use of moisturizer, gentle cleaning, and sunscreen use.
Anticipated results and applications:
This study expects to
- understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with optical coherence tomography and other noninvasive methods.
- Set evidence based guidance for melasma treatment and set the protocol or clinical path.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to sign a written inform consent form
- •Adults over the age of
- •Patients with melasma on their faces.
排除标准
- •have received any cosmetic treatments, e.g. laser, pulsed light, and chemical peels within six months before participating the trial.
- •Have taken oral contraceptives or received hormone therapy within one year before participating the trial.
- •Has other pigmented diseases or inflammatory diseases on face.
- •Are pregnant or breastfeeding.
- •Has conditions with poor wound healing, keloids or photosensitivity.
结局指标
主要结局
Improvement of MASI score
时间窗: 4 weeks
Improvement of melasma after picosecond laser treatment will be assessed using MASI score that will be calculated according to the image taken by VISIA at week 0, week 4, week 8, and week 12.
Number of subjects with clear tissue characteristics of melasma and/or normal skin in tomograms
时间窗: 4 weeks
Number of subjects with clear tissue characteristics of tomograms will be compared to that with unclear tissue characteristics to identify the effect of the OCT on scanning melasma at study completion.
Clinical improvement of melasma
时间窗: 4 weeks
Clinical improvement of melasma after picosecond laser treatment will be assessed by both physician and patient at week 0, week 4, week 8, and week 12.
Improvement of hydration, TEWL, viscoelasticity, or melanin and erythema index
时间窗: 4 weeks
Improvement of melasma after picosecond laser treatment will be assessed using Cutometer® MPA 580 at week 0, week 4, week 8, and week 12.
次要结局
- Number of subjects with the distinction between melasma and normal skin in tomograms(1 year)
研究者
Chang Chang Cheng
Director
China Medical University Hospital