Clinical trial NCT05386368: RECELL to Promote Healing Following Carbon Dioxide (CO2) Laser Treatment in Cosmetic Patients
Official title: Application of RECELL to Promote Healing Following CO2 Laser Treatment in Cosmetic Facelift Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Carbon Dioxide Laser
Photoaging
Keywords: Laser
Facelift
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Avita Medical
First posted: 2022-05-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model 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 - . 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Skin Sensitivity Scores - Redness
timeFrame: month 3
measure: Change in Skin Sensitivity Scores - Sensitivity to Light
timeFrame: month 3
measure: Change in Skin Sensitivity Scores - Tightness
timeFrame: month 3
measure: Change in Skin Sensitivity Scores - Itching
timeFrame: month 3
measure: Change in Skin Sensitivity Scores - Burning
timeFrame: month 3
measure: Change in Wong-Baker FACES Pain Assessment Tool Scores
timeFrame: Month 3
Secondary outcomes:
measure: Healing Within 2 Weeks Post-op
timeFrame: month 3
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joseph Molnar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: