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RECELL to Promote Healing Following Carbon Dioxide (CO2) Laser Treatment in Cosmetic Patients

Photoaging Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05386368
Study type Interventional
Source Wake Forest University Health Sciences
Contact Renea D Jennings, BSN
Phone 336-716-6709
Email rjenning@wakehealth.edu
Status Recruiting
Phase Phase 4
Start date March 22, 2023
Completion date December 2025
View Details
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