NCT03948945已完成不适用
Efficacy and Safety of Profile HaloTM Dual-wavelength Fusion Fractional Laser on the Treatment of Facial and Neck Photoaging: a Self-controlled Trial.
xjpfW0 个研究点目标入组 15 人开始时间: 2015年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- VISIA skin test
研究概览
简要总结
- Fractional laser has become an important laser modality in management of a number of skin conditions and photoaging. Fractional photothermolysis is the fractional emission of light into microscopic treatment zones, creating small columns of injury to the skin in a pixilated fashion. Epidermal and dermal disruptions occur in these focal zones of thermal injury, stimulating dermal collagen production and elastic tissue formation. Fractional laser has been used successfully to treat photodamage and overall dyschromia in the Caucasian population. However, there is not much improvement in Asian population.
- Photoaging refers to the skin caused by intense and chronic exposure to sunlight. The visible effects of photoaging are fine wrinkles, mottling, pigmentation and roughness of the skin. These changes are usually associated with chronologic aging. However, photoaging is not a good indicator of chronologic age. It just makes a person look older than his or her chronologic age. Skin ageing may be divided into two processes: intrinsic ageing and extrinsic ageing (or photoageing). Both are accompanied by changes in the morphological and biomechanical properties of skin.
- Profile HaloTM dual-wavelength fusion fractional laser is the first hand tool in the world that integrates ablative and non-ablative fractional lasers. It includes a non-ablative fractional laser with a wavelength of 1470nm and an ablative fractional laser with a wavelength of 2940nm. A day after treatment, new epithelial tissue began to appear, and the necrotic epidermis formed microepidermal necrotic debris (MENDs). MENDs were surrounded by keratin 2-7 days after treatment, and collagen sequence in MTZs was changed 7 days later. The 2940 ablative fractional laser can be added with 20-100 micron lattice stripping, ensuring safety while enabling MENDs to be peeled off 2 days earlier and reducing the risk of side effects. This makes the laser safe and effective compared with the single fractional laser and reduces the downtime.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be clinically diagnosed by the investigator to facial photoaging dover 2-4 and cervical stripe Fitzpatrick 1-2.5
- •no other treatment was performed for the skin lesions for half a year before the treatment
- •patients with a "no" in any of the above criteria are not eligible for inclusion
排除标准
- •subjects with a recent history of exposure to sunlight;
- •subjects allergic to topical anesthesia;
- •subjects with scar constitution;
- •subjects with skin malignant tumors or precancerous lesions; .subjects with diabetes, heart disease, epilepsy, connective tissue disease, etc.
- •subjects who Pregnant or breast feeding;
- •subjects with recent skin infections (such as viruses, bacteria, etc.);
- •ther methods are being used to treat subjects with similar diseases;
- •subject who have taken isotretinoin A in the past year; .subject with facial dermatitis.
结局指标
主要结局
VISIA skin test
时间窗: change from week0 to week48
With fast capture times and lighting modes designed to enhance the visualization of skin features, VISIA®-CR (Canfield Scientific, Inc. USA) is the standard in repeatable clinical imaging. Visia CR imaging system can be used to assess the skin wrinkles, texture, pores and elasticity
次要结局
- Glogau Classification of Photoaging(change from week0 to week48)
- Neck (Fitzpatrick wrinkle grading)(week0,week48)
研究者
xjpfW
Head of Dermatology
Xijing Hospital
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