skin appearing more refreshed (greater than or equal to 91%). The majority reported improved overall satisfaction with their appearance (greater than or equal to 92%), natural looking results (greater than or equal to 86%), and a desire to have the same PLLA-SCA treatment again (greater than or equal to 84%). PLLA-SCA recipients indicated that they would recommend the treatment to a friend (greater than or equal to 88%). Other key satisfaction outcomes included feeling better about yourself (greater than or equal to 92%) and improved self-confidence (greater than or equal to 90%). Speed of recovery, denoted by the median time to return to
social engagement after PLLA-SCA treatment, ranged between 3.9 hours (after treatment 1) and 7.1 hours (after treatment 4).
Mean FACE-Q Rasch-transformed score was increased in the PLLA-SCA group from 35.2 at baseline to >73 (mean increase: 37.9-40.0) at months 7 through 12, indicating increased satisfaction, whereas mean scores decreased by 3.6-4.1 during the study period in the control group, indicating that satisfaction was not increased (Figure 5).
Subject photographs illustrating the improvements from baseline to month 12 are shown in Figure 6.
Safety Endpoints
The most common self-reported (diary card) post-treatment symptoms were tenderness (93.5%), bruising (93.5%), swelling (87.1%), and pain (83.9%), most of which were mild/moderate in intensity (97.8%). Among the 97 subjects randomized to receive PLLA-SCA, 20 (20.6%) experienced treatment-related/ injection procedure-related AEs (Table 4). Seventeen subjects (17.5%) in the PLLA-SCA group experienced mild treatment-related AEs and 3 (3.1%) had events that were moderate in severity. No serious treatment-related AEs were reported. The most common treatment-related AEs in the PLLA-SCA group were injection site bruising (11.3%), dizziness (2.1%), and headache (2.1%), all of which resolved within 1-13 days.
