Carbon Dioxide LaserPhase 4NCT05386368
RECELL to Promote Healing Following Carbon Dioxide (CO2) Laser Treatment in Cosmetic Patients
A Phase 4 study testing ReCell in people with Carbon Dioxide Laser and Photoaging, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Carbon Dioxide Laser, Photoaging
- What is being tested?
- ReCell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2023to 6 May 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years or older
- Patients undergoing facelift with perioral CO2 laser treatment
- Skin that is Fitzpatrick Score 1 or 2
Who cannot join
- Prior perioral CO2 laser resurfacing
- Allergy to components of preparation system
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Application of RECELL to Promote Healing Following CO2 Laser Treatment in Cosmetic Facelift Patients
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.
Read the 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
- Being tested
- ReCell
- Keywords
- Laser, Facelift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReCellDrug
Also called autologous cell harvesting
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).
| Study group | Role | What they receive |
|---|---|---|
| Right receives ReCell (A) | Other | Right perioral area of face receives ReCell/ Left receives saline Receives: Drug: ReCell |
| Left receives ReCell (B) | Other | Left perioral area of face receives ReCell/ Right receives saline Receives: Drug: ReCell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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
Measured: Month 3
Secondary outcomes (1)
Healing Within 2 Weeks Post-op
Quantificare LifeViz Camera will be used - yes/no whether healing occurred within first 2 weeks post-op
Measured: month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start22 Mar 2023
- Primary completion7 Jul 2023
- Study completion6 May 2024
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. PI decided to terminate due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carbon Dioxide LaserStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model 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 - . 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)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Avita Medical
- Responsible party
- Sponsor
- Investigators
- Joseph Molnar, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386368
- Sponsor's protocol ID
- IRB00085278
- Status last verified
- Mar 2024
- First submitted
- 17 May 2022
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan on sharing individual participant data with other researchers at this time.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of RECELL to Promote Healing Following CO2 Laser Treatment in Cosmetic Facelift Patients
- ClinicalTrials.gov ID
- NCT05386368
- Acronym / sponsor ID
- IRB00085278
- Conditions
- Carbon Dioxide Laser, Photoaging
- Keywords
- Laser, Facelift
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. PI decided to terminate due to slow enrollment.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Avita Medical
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model 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 - . 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)
| Arm | Type | Receives |
|---|---|---|
| Right receives ReCell (A) | Other | Drug: ReCellRight perioral area of face receives ReCell/ Left receives saline |
| Left receives ReCell (B) | Other | Drug: ReCellLeft perioral area of face receives ReCell/ Right receives saline |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years or older
- Patients undergoing facelift with perioral CO2 laser treatment
- Skin that is Fitzpatrick Score 1 or 2
Key exclusion criteria (2 listed)
- Prior perioral CO2 laser resurfacing
- Allergy to components of preparation system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReCellAlso: autologous cell harvestingThe 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). | Drug | Left receives ReCell (B), Right receives ReCell (A) |
Primary outcome
Change in Skin Sensitivity Scores - Redness
Time frame: month 3
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"
Change in Skin Sensitivity Scores - Sensitivity to Light
Time frame: month 3
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"
Change in Skin Sensitivity Scores - Tightness
Time frame: month 3
surveys will be given to address tightness - a scale of "not at all, A little, moderately, or extremely"
Change in Skin Sensitivity Scores - Itching
Time frame: month 3
surveys will be given to address itching - a scale of "not at all, A little, moderately, or extremely"
Change in Skin Sensitivity Scores - Burning
Time frame: month 3
surveys will be given to address burning - a scale of "not at all, A little, moderately, or extremely"
Change in Wong-Baker FACES Pain Assessment Tool Scores
Time frame: Month 3
Wong-Baker FACES Pain Rating Scale - 1-10 pain scale - the higher the score the more pain
1 secondary outcome
Healing Within 2 Weeks Post-op
Time frame: month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We do not plan on sharing individual participant data with other researchers at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Molnar, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ReCell in people with Carbon Dioxide Laser and Photoaging, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Sensitivity Scores - Redness (time frame: month 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.