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

NCT05386368 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00085278
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Carbon Dioxide Laser; Photoaging

Keywords

Laser; Facelift

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Healing Within 2 Weeks Post-op

  month 3

Study Arms (2)

Right receives ReCell (A)

OTHER

Right perioral area of face receives ReCell/ Left receives saline

Drug: ReCell

Left receives ReCell (B)

OTHER

Left perioral area of face receives ReCell/ Right receives saline

Drug: ReCell

Interventions

ReCell 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).

Also known as: autologous cell harvesting

Left receives ReCell (B); Right receives ReCell (A)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Avita Medical: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Results Point of Contact

• Title: Joseph Molnar MD
• Organization: Atrium Health Wake Forest Baptist

jmolnar@wakehealth.edu

336-716-4171

Study Officials

• Joseph Molnar, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 23, 2022
• Study Start: March 22, 2023
• Primary Completion: July 7, 2023
• Study Completion: May 6, 2024
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)