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

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

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.

Study Overview

• Status: Terminated
• Conditions: Photoaging; Carbon Dioxide Laser
• Intervention / Treatment: Drug: ReCell

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Right receives ReCell (A); Right perioral area of face receives ReCell/ Left receives saline	Drug: ReCell; The perioral area of the face will be treated with CO2 laser. 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. Intraoperatively, RECELL and Placebo will be provided to surgeons and assistants in opaque application devices prepared by a trained, designated study team member. Both the treatment and placebo sides, will be dressed with a standard autologous cell suspension post treatment dressing (Telfa Clear and Xeroform).; Other Names: autologous cell harvesting
Other: Left receives ReCell (B); Left perioral area of face receives ReCell/ Right receives saline	Drug: ReCell; The perioral area of the face will be treated with CO2 laser. 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. Intraoperatively, RECELL and Placebo will be provided to surgeons and assistants in opaque application devices prepared by a trained, designated study team member. Both the treatment and placebo sides, will be dressed with a standard autologous cell suspension post treatment dressing (Telfa Clear and Xeroform).; Other Names: autologous cell harvesting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Skin Sensitivity Scores - Redness	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"	month 3
Change in Skin Sensitivity Scores - Sensitivity to Light	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"	month 3
Change in Skin Sensitivity Scores - Tightness	surveys will be given to address tightness - a scale of "not at all, A little, moderately, or extremely"	month 3
Change in Skin Sensitivity Scores - Itching	surveys will be given to address itching - a scale of "not at all, A little, moderately, or extremely"	month 3
Change in Skin Sensitivity Scores - Burning	surveys will be given to address burning - a scale of "not at all, A little, moderately, or extremely"	month 3
Change in Wong-Baker FACES Pain Assessment Tool Scores	Wong-Baker FACES Pain Rating Scale - 1-10 pain scale - the higher the score the more pain	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Within 2 Weeks Post-op	Quantificare LifeViz Camera will be used - yes/no whether healing occurred within first 2 weeks post-op	month 3

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Avita Medical
• Investigators: Principal Investigator: Joseph Molnar, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): May 6, 2024

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Laser; Facelift
• Other Study ID Numbers: IRB00085278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan on sharing individual participant data with other researchers at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No