跳至主要内容
临床试验/NCT00990431
NCT00990431已完成4 期

Ablative Fractional Lasers (CO2 and Er:YAG): A Randomized Controlled Blinded Split-face Trial of the Treatment of Peri-orbital Rhytides

Laserklinik Karlsruhe2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2008年8月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
28
试验地点
2
主要终点
Objective wrinkle depth

研究概览

简要总结

Ablative fractional lasers were introduced for treating facial rhytides in an attempt to achieve results comparable to traditional ablative resurfacing but with fewer side effects. However, there is conflicting evidence on how well this goal has generally been achieved as well as on the comparative value of fractional CO2 and Er:YAG lasers. The present study compares these modalities in a randomized controlled blinded split-face study design:

28 patients were enrolled and completed the entire study. Patients were randomly assigned to receive a single treatment on each side of the peri-orbital region, one with a fractional CO2 and one with a fractional Er:YAG laser. The evaluation included Fitzpatrick wrinkle score, profilometric measurement of wrinkle depth (both before and 3 months after treatment) as well as assessment of side effects and patient satisfaction (1, 3, 6 days and 3 months after treatment).

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age 40-55
  • mild to moderate peri-orbital rhytides

排除标准

  • unrealistic expectations
  • inability to meet follow-up criteria
  • Fitzpatrick skin phototype >III
  • coagulation disorders or anti-coagulant treatment
  • allergy to lidocaine or tetracaine
  • oral isotretinoin within the last 6 months
  • any active skin disease within the treatment areas (e. g., cancer, autoimmune disease)
  • synthetic implants in the treatment area
  • facial cosmetic procedures affecting the treatment area within the last 6 months
  • photosensitizing medications (e. g., tetracycline, gold)
  • history of keloid formation
  • pregnancy

结局指标

主要结局

Objective wrinkle depth

时间窗: 3 months

Wrinkle severity (according to Fitzpatrick´s wrinkle score)

时间窗: 3 months

次要结局

  • Patient satisfaction(3 months)

研究者

发起方
Laserklinik Karlsruhe
申办方类型
Other

研究点 (2)

Loading locations...

相似试验