| Outcome | Time on trial | Results N = 18 |
| Independent evaluator’s photograph assessment of severity on a 7-point ordinal scale |
|
|
| Primary End-point No. (%) with at least 2-point improvement from baseline score | Baseline | 0 (0) |
|
| 6-month post treatment | 1 (6) |
|
| 12-month post treatment | 4 (22) |
| No. (%) with at least 1-point improvement from baseline score | Baseline | 0 (0) |
|
| 6-month post treatment | 8 (44) |
|
| 12-month post treatment | 15 (83) |
| No. (%) with no improvement (change from baseline 0 or worst) from baseline score | Baseline | 18 (100) |
|
| 6-month post treatment | 10 (56) |
|
| 12-month post treatment | 6 (17) |
| Investigator’s live assessment of severity on a 7-point ordinal scale |
|
|
| No. (%) with at least 2-point improvement from baseline score | Baseline | 0 (0) |
|
| 6-month post treatment | 6 (33) |
|
| 12-month post treatment | 6 (33) |
| No. (%) with at least 1-point improvement from baseline score | Baseline | 0 (0) |
|
| 6-month post treatment | 8 (44) |
|
| 12-month post treatment | 14 (78) |
| No. (%) with no improvement (change from baseline 0 or worst) from baseline score | Baseline | 18 (100) |
|
| 6-month post treatment | 10 (56) |
|
| 12-month post treatment | 3 (17) |
| Patient’s self-assessment of satisfaction with the change in facial contour defects before and after treatment on a 5-point ordinal scale (5 very dissatisfied, 1 very satisfied) |
|
|
| Median Score (interquartile range) | Baseline | 4 (1) |
|
| 6-month post treatment | 2 (0) |
|
| 12-month post treatment | 2 (0) |
| No. (%) with at least 1-point improvement from baseline score | Baseline | 0 (0) |
|
| 6-month post treatment | 18 (100) |
|
| 12-month post treatment | 18 (100) |