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

NCT ID: NCT05386368

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2024-05-06

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.

Conditions

Carbon Dioxide Laser; Photoaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Right receives ReCell (A)

Right perioral area of face receives ReCell/ Left receives saline

Group Type: OTHER

ReCell

Intervention Type: DRUG

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).

Left receives ReCell (B)

Left perioral area of face receives ReCell/ Right receives saline

Group Type: OTHER

ReCell

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

autologous cell harvesting

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avita Medical

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Molnar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00085278

Identifier Type: -

Identifier Source: org_study_id