Table 2.
Patient Demographics and Baseline Characteristics (ITT Population)
| HAEYE-needle (n = 148) |
HAEYE-cannula (n = 139) |
HAEYE-pooled (n = 287) |
Control (n = 46) |
Total (n = 333) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Age (years) | ||||||||||
| Mean (SD) | 44.3 (12.15) | 44.2 (10.98) | 44.3 (11.58) | 45.5 (12.27) | 44.4 (11.67) | |||||
| Range | 22-73 | 24-72 | 22-73 | 24-63 | 22-73 | |||||
| >45 years, n (%) | 71 (48.0) | 69 (49.6) | 140 (48.8) | 22 (47.8) | 162 (48.6) | |||||
| Sex, n (%) | ||||||||||
| Female | 130 (87.8) | 122 (87.8) | 252 (87.8) | 38 (82.6) | 290 (87.1) | |||||
| Male | 18 (12.2) | 17 (12.2) | 35 (12.2) | 8 (17.4) | 43 (12.9) | |||||
| Race, n (%) | ||||||||||
| White | 133 (89.9) | 124 (89.2) | 257 (89.5) | 39 (84.8) | 296 (88.9) | |||||
| Black/African American | 5 (3.4) | 12 (8.6) | 17 (5.9) | 4 (8.7) | 21 (6.3) | |||||
| Asian | 3 (2.0) | 1 (0.7) | 4 (1.4) | 1 (2.2) | 5 (1.5) | |||||
| Native Hawaiian or other Pacific Islander | 0 | 1 (0.7) | 1 (0.3) | 0 | 1 (0.3) | |||||
| Other | 7 (4.7) | 1 (0.7) | 8 (2.8) | 2 (4.3) | 10 (3.0) | |||||
| Ethnicity, n (%) | ||||||||||
| Hispanic or Latino | 40 (27.0) | 26 (18.7) | 66 (23.0) | 9 (19.6) | 75 (22.5) | |||||
| Not Hispanic or Latino | 108 (73.0) | 113 (81.3) | 221 (77.0) | 37 (80.4) | 258 (77.5) | |||||
| Fitzpatrick skin type, n (%) | ||||||||||
| I–III | 97 (65.5) | 100 (71.9) | 197 (68.6) | 31 (67.4) | 228 (68.5) | |||||
| IV | 36 (24.3) | 26 (18.7) | 62 (21.6) | 10 (21.7) | 72 (21.6) | |||||
| V | 9 (6.1) | 4 (2.9) | 13 (4.5) | 3 (6.5) | 16 (4.8) | |||||
| VI | 6 (4.1) | 9 (6.5) | 15 (5.2) | 2 (4.3) | 17 (5.1) | |||||
| Blinded evaluator GIHS score, n (%) | Right | Left | Right | Left | Right | Left | Right | Left | Right | Left |
| 2 | 79 (53.4) | 76 (51.4) | 68 (48.9) | 71 (51.1) | 147 (51.2) | 147 (51.2) | 24 (52.2) | 27 (58.7) | 171 (51.4) | 174 (52.3) |
| 3 | 69 (46.6) | 72 (48.6) | 71 (51.1) | 68 (48.9) | 140 (48.8) | 140 (48.8) | 22 (47.8) | 19 (41.3) | 162 (48.6) | 159 (47.7) |
A no-treatment control arm was utilized for comparison with HAEYE-needle and HAEYE-cannula treatment groups throughout the study. The ITT population comprised all patients who were randomized to the study at baseline. HAEYE-pooled included all patients receiving HAEYE treatment by needle or cannula. GIHS, Galderma infraorbital hollow scale; HAEYE, Restylane Eyelight hyaluronic acid treatment; ITT, intention-to-treat; SD, standard deviation.