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RECELL for Carbon Dioxide Laser Recovery
Phase 4
Recruiting
Led By Joseph Molnar, MD, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing facelift with perioral CO2 laser treatment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
Awards & highlights
Study Summary
This trial will test whether using a person's own cells to treat side effects of CO2 laser treatment can reduce healing time.
Who is the study for?
This trial is for adults over 18 with a light skin tone (Fitzpatrick Score 1 or 2) who are getting a facelift and CO2 laser treatment around the mouth. It's not for those who've had perioral CO2 laser resurfacing before or have allergies to the ReCell system components.Check my eligibility
What is being tested?
The study tests if using ReCell, which involves applying your own cells after they're prepared through special processes, can reduce side effects from CO2 laser treatments and speed up healing of the skin.See study design
What are the potential side effects?
While specific side effects aren't listed, generally procedures like this could cause redness, swelling, sensitivity at the application site, infection risk or an allergic reaction to the preparation used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am getting a facelift and CO2 laser treatment around my mouth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in FACE-Q scale scores
Change in Skin sensitivity scores - burning
Change in Skin sensitivity scores - itching
+4 moreSecondary outcome measures
Healing within 2 weeks post-op
Trial Design
2Treatment groups
Experimental Treatment
Group I: Right receives ReCell (A)Experimental Treatment1 Intervention
Right perioral area of face receives ReCell/ Left receives saline
Group II: Left receives ReCell (B)Experimental Treatment1 Intervention
Left perioral area of face receives ReCell/ Right receives saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ReCell
2015
Completed Phase 4
~30
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,244 Previous Clinical Trials
1,004,778 Total Patients Enrolled
Avita MedicalIndustry Sponsor
15 Previous Clinical Trials
640 Total Patients Enrolled
Joseph Molnar, MD, PhDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
17 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had CO2 laser treatment around my mouth.I am 18 years old or older.I am getting a facelift and CO2 laser treatment around my mouth.You are allergic to any of the ingredients in the medication.
Research Study Groups:
This trial has the following groups:- Group 1: Left receives ReCell (B)
- Group 2: Right receives ReCell (A)
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this scientific experiment still enrolling participants?
"Visiting clinicaltrials.gov, we can confirm that this study is not accepting new participants at present, as the last update to it occurred on November 27th 2022. Despite its lack of recruitment activity, there are currently 6 other medical studies looking for patients right now."
Answered by AI
Are elderly individuals being included in the recruitment process of this research?
"Eligible participants for this medical research must be aged 18 or older but no more than 99 years old."
Answered by AI
To what extent might this treatment be hazardous to those engaging in it?
"The safety of this particular therapeutic intervention is deemed as level 3 due to it being a Phase 4 trial, indicating the approval and extensive clinical research that has already been conducted."
Answered by AI
Who qualifies to partake in this investigation?
"This trial is aiming to accept 10 participants, ranging from 18 years of age to 99. The key inclusion criteria for enrolment include: adults aged over 18; Fitzpatrick Score 1 or 2 skin type; and a current carbon dioxide laser treatment related facelift procedure."
Answered by AI
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