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

Last updated: August 1, 2024
Sponsor: Wake Forest University Health Sciences
Overall Status: Terminated

Phase

4

Condition

Skin Aging

Treatment

ReCell

Clinical Study ID

NCT05386368
IRB00085278
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults 18 years or older

  • Patients undergoing facelift with perioral CO2 laser treatment

  • Skin that is Fitzpatrick Score 1 or 2

Exclusion

Exclusion Criteria:

  • Prior perioral CO2 laser resurfacing

  • Allergy to components of preparation system

Study Design

Total Participants: 1
Treatment Group(s): 1
Primary Treatment: ReCell
Phase: 4
Study Start date:
March 22, 2023
Estimated Completion Date:
May 06, 2024

Study 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.

Connect with a study center

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.