| Primary | Visual Comparison of Ecchymosis at Postoperative Day 3 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. | Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis. | Posted | | Number | | participants | | Through Postoperative Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Participants With Less Ecchymosis Treated With FS VH S/D 4 | | | OG001 | Participants With Less Ecchymosis Treated With SoC | | | OG002 | Participants With Equal Ecchymosis On Both Sides | | | OG003 | Participants With No Ecchymosis on Either Side | |
| | Units | Counts |
|---|
| Participants | - OG00028
- OG00128
- OG00228
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0005
- OG00112
- OG00211
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | McNemar | | 0.143 | | Difference in Proportions | 0.250 | | | | 95 | -0.04 | 0.49 | | | Difference in Proportions = SoC - FS VH S/D 4 | No | Superiority or Other | | |
|
| Secondary | Visual Comparison of Ecchymosis at Day 1 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. | Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis. | Posted | | Number | | participants | | Through Postoperative Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Participants With Less Ecchymosis Treated With FS VH S/D 4 | | | OG001 | Participants With Less Ecchymosis Treated With SoC | | | OG002 | Participants With Equal Ecchymosis On Both Sides | | | OG003 | Participants With No Ecchymosis on Either Side | |
| |
| Secondary | Visual Comparison of Ecchymosis at Day 5 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. | Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis. | Posted | | Number | | participants | | Through Postoperative Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Participants With Less Ecchymosis Treated With FS VH S/D 4 | | | OG001 | Participants With Less Ecchymosis Treated With SoC | | | OG002 | Participants With Equal Ecchymosis On Both Sides | | | OG003 | Participants With No Ecchymosis on Either Side | |
| |
| Secondary | Visual Comparison of Ecchymosis at Day 7 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. | Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis. | Posted | | Number | | participants | | Through Postoperative Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Participants With Less Ecchymosis Treated With FS VH S/D 4 | | | OG001 | Participants With Less Ecchymosis Treated With SoC | | | OG002 | Participants With Equal Ecchymosis On Both Sides | | | OG003 | Participants With No Ecchymosis on Either Side | |
| |
| Secondary | Visual Comparison of Ecchymosis at Day 10 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. | Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis. | Posted | | Number | | participants | | Through Postoperative Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Participants With Less Ecchymosis Treated With FS VH S/D 4 | | | OG001 | Participants With Less Ecchymosis Treated With SoC | | | OG002 | Participants With Equal Ecchymosis On Both Sides | | | OG003 | Participants With No Ecchymosis on Either Side | |
| |
| Secondary | Visual Comparison of Ecchymosis at Day 14 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. | Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis. | Posted | | Number | | participants | | Through Postoperative Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Participants With Less Ecchymosis Treated With FS VH S/D 4 | | | OG001 | Participants With Less Ecchymosis Treated With SoC | | | OG002 | Participants With Equal Ecchymosis On Both Sides | | | OG003 | Participants With No Ecchymosis on Either Side | |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved Statistical Analysis Plan (SAP) specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 10 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 14 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by a Blinded On-site Evaluator-Day 3 | Difference between each side of the face are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | Full Range | Scores on a scale | | Postoperative Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1 | Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil, Grade 2= Minor, Grade 3= Moderate, Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3 | Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5 | Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7 | Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10 | Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14 | Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1 | Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3 | Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5 | Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7 | Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10 | Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14 | Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | 90% Confidence Interval | Scores on a scale | | Through Postoperative Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Facelift Participants | One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. |
| |
| Secondary | Resolution of Ecchymosis as Assessed by Investigators | Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all)) | | Posted | | Number | | participants | | Postoperative Days 1, 3, 5, 7, 10, and 14 | | | | ID | Title | Description |
|---|
| OG000 | Complete Resolution of Ecchymosis With FS VH S/D 4 But Not SoC | | | OG001 | Complete Resolution of Ecchymosis With SoC But Not FS VH S/D 4 | | | OG002 | Participants With Complete Resolution on Both Sides | | | OG003 | Participants With No Resolution on Either Side | |
| |
| Secondary | Resolution of Edema as Assessed by Investigators. | Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil) | | Posted | | Number | | participants | | Postoperative Days 1, 3, 5, 7, 10, and 14 | | | | ID | Title | Description |
|---|
| OG000 | Complete Resolution of Edema With FS VH S/D 4 But Not SoC | | | OG001 | Complete Resolution of Edema With SoC But Not FS VH S/D 4 | | | OG002 | Participants With Complete Resolution on Both Sides | | | OG003 | Participants With No Resolution on Either Side | |
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| Secondary | Total Volume of Drainage on Each Side of the Face | | | Posted | | Median | Full Range | mL | | 24 hours postoperative | | | | ID | Title | Description |
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| OG000 | Standard of Care (SoC) | | | OG001 | FS VH S/D 4 | |
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| Secondary | Participants With Hematoma/Seroma | Investigators assessed each side of the face for the presence of hematoma/seroma | | Posted | | Number | | Participants | | Days 0, 1, 3, 5, 7,10, and 14 | | | | ID | Title | Description |
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| OG000 | Standard of Care (SoC) | | | OG001 | FS VH S/D 4 | |
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| Secondary | Participants With Hematoma/Seroma During the Study | Investigators assessed each side of the face for the presence of hematoma/seroma | | Posted | | Number | | participants | | Through Postoperative Day 14 (± 1) | | | | ID | Title | Description |
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| OG000 | Participants With Hematoma/Seroma on FS VH S/D 4 Side | | | OG001 | Participants With Hematoma/Seroma on SoC Side | | | OG002 | Participants With Hematoma/Seroma on Both Sides | | | OG003 | Participants With No Hematoma/Seroma on Either Side | |
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| Secondary | Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14 | Two-point discrimination test performed by investigators to assess nerve regeneration. Testing performed on each side of the face (SoC and FS VH S/D 4). Differences are calculated as: Postoperative Day - Day 0, reported as minimal distance at which participants were able to discern feeling at two distinct points | | Posted | | Median | Full Range | mm | | Postoperative Days 3, 7, 10, and 14 | | | | ID | Title | Description |
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| OG000 | FS VH S/D 4 - Day3 | | | OG001 | SoC - Day 3 | | | OG002 | FS VH S/D 4 - Day 7 | | | OG003 | SoC - Day 7 | | | OG004 | FS VH S/D 4 - Day 10 | | | OG005 | SoC - Day 10 | | | OG006 |
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| Secondary | Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) | Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a pain assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the pain experienced, i.e. 10 = worst, 1 = least. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | Full Range | Scores on a scale | | Days 1, 3, 5, 7,10, and 14 | | | | ID | Title | Description |
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| OG000 | Facelift Participants | |
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| Secondary | Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) | Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a numbness assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the numbness experienced, i.e. 10 = worst, 1 = least. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | | Posted | | Median | Full Range | Scores on a scale | | Days 1, 3, 5, 7,10, and 14 | | | | ID | Title | Description |
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| OG000 | Facelift Participants | |
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| Secondary | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Participants compared the levels of bruising on each side of their face and determine if they had a preference for the look of 1 side over another. | | Posted | | Number | | participants | | Postoperative Days 1, 3, 5, 7, 10, and 14 | | | | ID | Title | Description |
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| OG000 | No Difference | | | OG001 | FS VH S/D 4 Looks Better | | | OG002 | SoC Looks Better | |
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| Primary | Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period | | | Posted | | Number | | Adverse Events | | Through Postoperative Day 14 (± 1) | | | | ID | Title | Description |
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| OG000 | Facelift Participants | |
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