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临床试验/NCT05386368
NCT05386368终止4 期

Application of RECELL to Promote Healing Following CO2 Laser Treatment in Cosmetic Facelift Patients

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2023年3月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
1
试验地点
1
主要终点
Change in Wong-Baker FACES Pain Assessment Tool Scores

研究概览

简要总结

To determine whether following Carbon dioxide (CO2) laser treatment, application of autologous cell suspension obtained via enzymatic and mechanical preparation will reduce negative side effects from CO2 laser and decrease the time of healing following treatment.

详细描述

The perioral area of the face will be treated with CO2 laser. Laser setting will be determined by the treating surgeon for each individual patient. Typical settings to be used for severe facial photoaging is Energy (mj) 100-125, Scan Size 6-7 mm, Density 2-3, Hertz 100-200, Repeat Delay 0.3-1.5 seconds, number of passes 2. The patient would be randomized and blinded to either left perioral or right perioral RECELL application. The surgeon would also be blinded to which side received RECELL treatment or Placebo (saline spray). Randomization would occur before study initiation with subjects assigned either left perioral or right perioral RECELL treatment based on their subject enrollment number. The study team member who prepares and blinds the RECELL will create the list of subject ID numbers with subject ID number randomly assigned to either left perioral or right perioral treatment group. This will be completed prior to any patient enrollment in the study. This spreadsheet will be password protected and only accessible to study coordinators and the team member responsible for preparing RECELL.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The patient would be randomized and blinded to either left perioral or right perioral RECELL application. The surgeon would also be blinded to which side received RECELL treatment or Placebo (saline spray).

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults 18 years or older
  • Patients undergoing facelift with perioral CO2 laser treatment
  • Skin that is Fitzpatrick Score 1 or 2

排除标准

  • Prior perioral CO2 laser resurfacing
  • Allergy to components of preparation system

研究组 & 干预措施

Right receives ReCell (A)

Other

Right perioral area of face receives ReCell/ Left receives saline

干预措施: ReCell (Drug)

Left receives ReCell (B)

Other

Left perioral area of face receives ReCell/ Right receives saline

干预措施: ReCell (Drug)

结局指标

主要结局

Change in Wong-Baker FACES Pain Assessment Tool Scores

时间窗: Month 3

Wong-Baker FACES Pain Rating Scale - 1-10 pain scale - the higher the score the more pain

Change in Skin Sensitivity Scores - Redness

时间窗: month 3

surveys will be given to address redness - a scale of "not at all, A little, moderately, or extremely" Scale is, "not at all", "a little", "moderately", "extremely"

Change in Skin Sensitivity Scores - Sensitivity to Light

时间窗: month 3

surveys will be given to address sensitivity to light - a scale of "not at all, A little, moderately, or extremely" Score is, "not at all", "a little", "moderately", "extremely"

Change in Skin Sensitivity Scores - Tightness

时间窗: month 3

surveys will be given to address tightness - a scale of "not at all, A little, moderately, or extremely"

Change in Skin Sensitivity Scores - Itching

时间窗: month 3

surveys will be given to address itching - a scale of "not at all, A little, moderately, or extremely"

Change in Skin Sensitivity Scores - Burning

时间窗: month 3

surveys will be given to address burning - a scale of "not at all, A little, moderately, or extremely"

次要结局

  • Healing Within 2 Weeks Post-op(month 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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