The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in striae roughness by Antera 3D image
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of a fractional 1,064 nm picosecond laser for the treatment of striae alba.
详细描述
Striae distensae are atrophic dermal scars that can cause psychosocial distress on affected patients. Despite numerous available therapeutic modalities, no gold standard therapy has been established. Picosecond lasers are a newer advancement in lasers that have primarily used in the treatment of tattoos. A fractional 1064-nm picosecond laser has recently become available for the treatment of pigmentation and skin rejuvenation. The main mechanism of action is tissue ablation via laser induced optical breakdown (LIOB) which occur when pulse intensity is high enough to strip electrons and generating plasma, the plasma absorbs the remaining laser energy forming a cavitation bubble within the dermis which has been demonstrated to improve fine wrinkles and acne scar through the stimulation of collagen formation.
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
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Striae alba on abdomen for more than 3 months
- •Fitzpatrick skin type III-V
排除标准
- •Pregnancy and breastfeeding
- •Previous topical treatment, filler injection, chemical peel or laser treatment within 6 months before starting the study
- •History of using Isotretinoin
- •Photosensitive dermatoses, Infection, eczema
- •Past history or family history of malignancy
- •History of herpes infection
- •History of hypertrophic scar or keloid, connective tissue disease
- •History of collagen or elastin disease
- •History of smoking
- •Significant fluctuations in weight in the past 6 months
结局指标
主要结局
Change in striae roughness by Antera 3D image
时间窗: change from baseline in striae roughness score at 6 months
Change in average Melanin index by Antera 3D image
时间窗: change from baseline in average melanin index at 6 months
Change in melanin variation index by Antera 3D image
时间窗: change from baseline in melanin variation index at 6 months
次要结局
- Investigator assessment scores(Baseline, 1, 3 and 6 months after final treatment)
- Patient satisfaction scores(Baseline, 1, 3, and 6 months after final treatment)
研究者
Woraphong Manuskiatti, M.D.
Professor
Mahidol University