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

NCT05386368 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-08-09

Study results available
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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

Interventions

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).

Sponsors & Collaborators

  • Avita Medical

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Joseph Molnar, MD, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2023-07-07
Completion
2024-05-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05386368 on ClinicalTrials.gov