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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05386368
• Other study ID #: IRB00085278
• Status: Recruiting
• Phase: Phase 4
• Start date: March 22, 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: Renea D Jennings, BSN
• Phone: 336-716-6709
• Email: rjenning[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carbon Dioxide Laser
• Photoaging

Intervention

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).

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Avita Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Skin sensitivity scores - redness	surveys will be given to address redness - a scale of "not at all, A little, moderately, or extremely"	month 3
Primary	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"	month 3
Primary	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
Primary	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
Primary	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
Primary	Change in FACE-Q scale scores	measure what participants think about their appearance, quality of life, adverse effects, and process of care - score from 0 to 100, with higher scores indicating a better outcome	Month 3
Primary	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	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