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Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. PI decided to terminate due to slow enrollment.
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| Name | Class |
|---|---|
| Avita Medical | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right receives ReCell (A) | Other | Right perioral area of face receives ReCell/ Left receives saline |
|
| Left receives ReCell (B) | Other | Left perioral area of face receives ReCell/ Right receives saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReCell | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 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" | 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" | 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" | 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" | 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 | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Healing Within 2 Weeks Post-op | Quantificare LifeViz Camera will be used - yes/no whether healing occurred within first 2 weeks post-op | month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Molnar, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
We do not plan on sharing individual participant data with other researchers at this time.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We only had one subject total and she received (A) Right receives Recell
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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" | We did not have any subjects that received (B) Left receives Recell | Posted | Number | # of participants reporting not at all | month 3 |
|
3 months
We did not have any participants randomized to receive ReCell on the Left side, so there were no participants at risk in this arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Molnar MD | Atrium Health Wake Forest Baptist | 336-716-4171 | jmolnar@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2023 | Jul 29, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2023 | Jul 29, 2024 | ICF_002.pdf |
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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)
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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).
|
|
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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). |
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|
| 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" | We did not have any subjects that received (B) Left receives Recell | Posted | Number | # of participants reporting not at all | month 3 |
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| 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" | We did not have any participants receive (B) Left receives ReCell | Posted | Number | # of participants reporting not at all | month 3 |
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|
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| 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" | We did not have any participants receive (B) Left receives ReCell | Posted | Number | # of participants reporting not at all | month 3 |
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| 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" | We did not have any participants receive (B) left receives ReCell | Posted | Number | # of participants reporting not at all | month 3 |
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| 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 | We did not have any participants receive (B) Left receives ReCell | Posted | Number | score on a scale | Month 3 |
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|
| Secondary | Healing Within 2 Weeks Post-op | Quantificare LifeViz Camera will be used - yes/no whether healing occurred within first 2 weeks post-op | We did not have any participants receive (B) left receives ReCell | Posted | Number | percentage of participants with healing | month 3 |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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