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

Wake Forest University (WFU)

Status and phase: Terminated; Phase 4

Conditions: Carbon Dioxide Laser; Photoaging

Treatments: Drug: ReCell

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05386368

IRB00085278

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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1 participants in 2 patient groups

Right receives ReCell (A)

Other group

Description:

Right perioral area of face receives ReCell/ Left receives saline

Treatment:

Drug: ReCell

Left receives ReCell (B)

Other group

Description:

Left perioral area of face receives ReCell/ Right receives saline

Treatment:

Drug: ReCell