Trial Outcomes & Findings for RECELL to Promote Healing Following Carbon Dioxide (CO2) Laser Treatment in Cosmetic Patients (NCT NCT05386368)
NCT ID: NCT05386368
Last Updated: 2024-08-09
Results Overview
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"
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
1 participants
Primary outcome timeframe
month 3
Results posted on
2024-08-09
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RECELL to Promote Healing Following Carbon Dioxide (CO2) Laser Treatment in Cosmetic Patients
Baseline characteristics by cohort
| Measure |
Right Receives ReCell (A)
n=1 Participants
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).
|
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).
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
71 years
n=5 Participants
|
—
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: month 3Population: We did not have any subjects that received (B) Left receives Recell
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"
Outcome measures
| Measure |
Right Receives ReCell (A)
n=1 Participants
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).
|
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).
|
|---|---|---|
|
Change in Skin Sensitivity Scores - Redness
|
1 # of participants reporting not at all
|
—
|
PRIMARY outcome
Timeframe: month 3Population: We did not have any subjects that received (B) Left receives Recell
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"
Outcome measures
| Measure |
Right Receives ReCell (A)
n=1 Participants
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).
|
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).
|
|---|---|---|
|
Change in Skin Sensitivity Scores - Sensitivity to Light
|
1 # of participants reporting not at all
|
—
|
PRIMARY outcome
Timeframe: month 3Population: We did not have any participants receive (B) Left receives ReCell
surveys will be given to address tightness - a scale of "not at all, A little, moderately, or extremely"
Outcome measures
| Measure |
Right Receives ReCell (A)
n=1 Participants
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).
|
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).
|
|---|---|---|
|
Change in Skin Sensitivity Scores - Tightness
|
1 # of participants reporting not at all
|
—
|
PRIMARY outcome
Timeframe: month 3Population: We did not have any participants receive (B) Left receives ReCell
surveys will be given to address itching - a scale of "not at all, A little, moderately, or extremely"
Outcome measures
| Measure |
Right Receives ReCell (A)
n=1 Participants
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).
|
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).
|
|---|---|---|
|
Change in Skin Sensitivity Scores - Itching
|
1 # of participants reporting not at all
|
—
|
PRIMARY outcome
Timeframe: month 3Population: We did not have any participants receive (B) left receives ReCell
surveys will be given to address burning - a scale of "not at all, A little, moderately, or extremely"
Outcome measures
| Measure |
Right Receives ReCell (A)
n=1 Participants
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).
|
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).
|
|---|---|---|
|
Change in Skin Sensitivity Scores - Burning
|
1 # of participants reporting not at all
|
—
|
PRIMARY outcome
Timeframe: Month 3Population: We did not have any participants receive (B) Left receives ReCell
Wong-Baker FACES Pain Rating Scale - 1-10 pain scale - the higher the score the more pain
Outcome measures
| Measure |
Right Receives ReCell (A)
n=1 Participants
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).
|
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).
|
|---|---|---|
|
Change in Wong-Baker FACES Pain Assessment Tool Scores
|
0 score on a scale
|
—
|
SECONDARY outcome
Timeframe: month 3Population: We did not have any participants receive (B) left receives ReCell
Quantificare LifeViz Camera will be used - yes/no whether healing occurred within first 2 weeks post-op
Outcome measures
| Measure |
Right Receives ReCell (A)
n=1 Participants
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).
|
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).
|
|---|---|---|
|
Healing Within 2 Weeks Post-op
|
100 percentage of participants with healing
|
—
|
Adverse Events
Right Receives ReCell (A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Left Receives ReCell (B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place