RECELL to Promote Healing Following Carbon Dioxide (CO2) Laser Treatment in Cosmetic Patients
- Conditions
- PhotoagingCarbon Dioxide Laser
- Interventions
- Drug: ReCell
- Registration Number
- NCT05386368
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- Adults 18 years or older
- Patients undergoing facelift with perioral CO2 laser treatment
- Skin that is Fitzpatrick Score 1 or 2
- Prior perioral CO2 laser resurfacing
- Allergy to components of preparation system
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Right receives ReCell (A) ReCell Right perioral area of face receives ReCell/ Left receives saline Left receives ReCell (B) ReCell Left perioral area of face receives ReCell/ Right receives saline
- Primary Outcome Measures
Name Time Method Change in Wong-Baker FACES Pain Assessment Tool Scores 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 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 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 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 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 month 3 surveys will be given to address burning - a scale of "not at all, A little, moderately, or extremely"
- Secondary Outcome Measures
Name Time Method Healing Within 2 Weeks Post-op month 3 Quantificare LifeViz Camera will be used - yes/no whether healing occurred within first 2 weeks post-op
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States