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临床试验/NCT06486727
NCT06486727尚未招募不适用

Efficacy and Safety of 675-nm Laser for Dorsal Hand Rejuvenation in Thai Patients

Mahidol University0 个研究点目标入组 26 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
26
主要终点
The change in pigmentation level, wrinkle and texture

研究概览

简要总结

This study aimed to evaluate efficacy and safety of 675-nm laser for dorsal hand rejuvenation in Thai patients. Twenty-six subjects aged 50 to 65 years diagnosed with wrinkle and solar lentigines on both dorsums of hands were included and treated with RedTouch for 3 times every 4 weeks. Then, they were follow up at 3 and 6 months after the final treatment. The measurement of 5-point Global Aesthetic Improvement Scale scores by physicians and subjects were conducted. Moreover, pigmentation level, wrinkle and texture were also recored using Antera. Elasticity was measured using Cutometer.

详细描述

RedTouch parameter included Moveo, power 5 W, Energy/DOT 500 mJ/DOT, then Standard, power 4 W, spacing 2000 μm, 1 pass per side.

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
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects diagnosed with wrinkles and solar lentigines on both dorsum of hands

排除标准

  • Pregnant or lactation
  • Sugjects with a history of allergy to near-infrared wavelength or photosensitizing agents
  • Subjects who have been treated with any kind of energy-based device on both dorsum of hands 6 months prior to the inclusion
  • Subjects who have been injected with filler, or platelet-rich plasma on both dorsum of hands on their faces 6 months prior to the inclusion
  • Active skin infections
  • History of hypertrophic scars or keloids

结局指标

主要结局

The change in pigmentation level, wrinkle and texture

时间窗: Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment

Using Antera®

次要结局

  • The change in elasticity(Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment)
  • Overall improvement by physicians and patients(4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment)
  • Adverse events(4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment)
  • Pain score(Baseline, 4, 8, 12 weeks after the first treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Woraphong Manuskiatti, M.D.

Prof. Dr.

Mahidol University

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