Carbon Dioxide Laser, Photoaging
Conditions
Keywords
Laser, Facelift
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.
Interventions
DRUGReCell
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
Avita Medical
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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).
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Sensitivity Scores - Tightness | 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 - Redness | 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 | 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 Wong-Baker FACES Pain Assessment Tool Scores | Month 3 | Wong-Baker FACES Pain Rating Scale - 1-10 pain scale - the higher the score the more pain |
| Change in Skin Sensitivity Scores - Itching | 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 | month 3 | surveys will be given to address burning - a scale of not at all, A little, moderately, or extremely |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healing Within 2 Weeks Post-op | month 3 | Quantificare LifeViz Camera will be used - yes/no whether healing occurred within first 2 weeks post-op |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Right Receives ReCell (A) Right perioral area of face receives ReCell/ Left receives saline
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). | 1 |
| Left Receives ReCell (B) Left perioral area of face receives ReCell/ Right receives saline
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). | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Right Receives ReCell (A) | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants |
| Age, Continuous | 71 years | 71 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Change in Skin Sensitivity Scores - Burning
surveys will be given to address burning - a scale of not at all, A little, moderately, or extremely
Time frame: month 3
Population: We did not have any participants receive (B) left receives ReCell
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Right Receives ReCell (A) | Change in Skin Sensitivity Scores - Burning | 1 # of participants reporting not at all |
Primary
Change in Skin Sensitivity Scores - Itching
surveys will be given to address itching - a scale of not at all, A little, moderately, or extremely
Time frame: month 3
Population: We did not have any participants receive (B) Left receives ReCell
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Right Receives ReCell (A) | Change in Skin Sensitivity Scores - Itching | 1 # of participants reporting not at all |
Primary
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
Time frame: month 3
Population: We did not have any subjects that received (B) Left receives Recell
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Right Receives ReCell (A) | Change in Skin Sensitivity Scores - Redness | 1 # of participants reporting not at all |
Primary
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
Time frame: month 3
Population: We did not have any subjects that received (B) Left receives Recell
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Right Receives ReCell (A) | Change in Skin Sensitivity Scores - Sensitivity to Light | 1 # of participants reporting not at all |
Primary
Change in Skin Sensitivity Scores - Tightness
surveys will be given to address tightness - a scale of not at all, A little, moderately, or extremely
Time frame: month 3
Population: We did not have any participants receive (B) Left receives ReCell
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Right Receives ReCell (A) | Change in Skin Sensitivity Scores - Tightness | 1 # of participants reporting not at all |
Primary
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
Time frame: Month 3
Population: We did not have any participants receive (B) Left receives ReCell
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Right Receives ReCell (A) | Change in Wong-Baker FACES Pain Assessment Tool Scores | 0 score on a scale |
Secondary
Healing Within 2 Weeks Post-op
Quantificare LifeViz Camera will be used - yes/no whether healing occurred within first 2 weeks post-op
Time frame: month 3
Population: We did not have any participants receive (B) left receives ReCell
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Right Receives ReCell (A) | Healing Within 2 Weeks Post-op | 100 percentage of participants with healing |