A Comparison of 1550-nm Fractional Photothermolysis Versus Intense Focused Ultrasound for Treatment of Periorbital Wrinkles: A Pilot, Prospective Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quantitative eyelid laxity scale
研究概览
简要总结
The primary objective of this study is to compare the efficacy of intense focused ultrasound and carbon dioxide-fractionated laser for treatment of periorbital wrinkles.
详细描述
This is a prospective randomized comparison study comparing the efficacy of micro-focused ultrasound versus fractionated carbon dioxide laser for treatment of periorbital wrinkles. Subjects who meet inclusion and exclusion criteria will be enrolled in the study. The treated sites are both lower eyelids and lateral orbits. Each side will be randomized to receive 1550nm-fractionated laser treatment on one side and the contralateral side will receive micro-focused ultrasound treatment every 6-8 weeks for a total of 2 treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 35-60 years old male and female subjects with moderate lower eyelid rhytids and crowsfeet
- •Subjects with Fitzpatrick skin type I-III.
- •Subjects who are willing, have the ability to understand and provide informed consent, and are able to communicate with the investigator.
排除标准
- •Subjects who have received injectable soft-tissue augmentation materials to the face, or facial ablative resurfacing, within the past 6 months.
- •Subjects who were received injectable botulinum toxin to the face, or any nonablative laser treatment to the face, within the past 3 months.
- •Subjects who have local infections, open facial wounds, or other significant local skin disease that would interfere with periorbital treatment with energy devices.
- •Subjects who are allergic to lidocaine or prilocaine.
- •Subjects who have a history of abnormal scarring in the treatment area.
- •Subject who have ectropion or or other eyelid disfigurement.
- •Subjects who have history of isotretinoin use in the preceding year
- •Pregnant or lactating individuals
研究组 & 干预措施
Fractional photothermolysis
Fractional photothermolysis (FP) for treatment of photo- damaged skin is an FDA-approved method for treating facial rhytids. Fractionated treatment with 1550-nm laser is a safe, nonsurgical method for improvement of periorbital rhytides, photodamage, and scarring
干预措施: Laser treatment (Procedure)
High-intensity focused ultrasound
High-intensity focused ultrasound (HIFUS) is an FDA-approved method for periorbital treatment and nonablative tissue tightening. Ultrasound waves induce a vibration in the tissue, generating heat and increasing the tissue temperature within a focal area. The tissue changes depend on amount of heat and exposure duration. These findings are similar to the thermally induced changes within the skin after CO2 laser fractional ablative treatments.
干预措施: Laser treatment (Procedure)
High-intensity focused ultrasound
High-intensity focused ultrasound (HIFUS) is an FDA-approved method for periorbital treatment and nonablative tissue tightening. Ultrasound waves induce a vibration in the tissue, generating heat and increasing the tissue temperature within a focal area. The tissue changes depend on amount of heat and exposure duration. These findings are similar to the thermally induced changes within the skin after CO2 laser fractional ablative treatments.
干预措施: High-intensity focused ultrasound (Device)
Fractional photothermolysis
Fractional photothermolysis (FP) for treatment of photo- damaged skin is an FDA-approved method for treating facial rhytids. Fractionated treatment with 1550-nm laser is a safe, nonsurgical method for improvement of periorbital rhytides, photodamage, and scarring
干预措施: High-intensity focused ultrasound (Device)
结局指标
主要结局
Quantitative eyelid laxity scale
时间窗: 3 months
Two non-treating dermatologists will independently blindly evaluate the photographs at baseline, 1 and 3 months after treatment; differences will be resolved via a forced agreement process.
Global Improvement Scale
时间窗: 3 months
Global improvement scale score, as a percent improvement from baseline to 1 and 3 months, respectively, after treatment. Two non-treating dermatologists will independently blindly evaluate the photographs at baseline, 1 and 3 months after treatment; differences will be resolved via a forced agreement process.
次要结局
- Subject Satisfaction(10 years)
- Adverse events(10 years)
研究者
Murad Alam
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation
Northwestern University