April 2020 HSC Section 4 - Plastic and Reconstructive Problems

ATX - 1 0 1 FOR M I LD AND EXTR EME SMF

TABLE 1. Demographic and Baseline Characteristics

Mild SMF,* n = 47

Extreme SMF,* n = 46

Placebo, n = 16 ATX-101, n = 31 Placebo, n = 16 ATX-101, n = 30

Age, mean (SD), yrs Sex, female, n (%)

48.4 (8.8)

48.6 (9.7) 29 (93.5)

50.1 (11.2)

52.1 (7.9) 25 (83.3)

16 (100)

8 (50.0)

Race, n (%) White

12 (75.0)

26 (83.9)

14 (87.5)

27 (90.0)

Black Asian Other

3 (18.8)

3 (9.7) 2 (6.5)

1 (6.3)

3 (10.0)

1 (6.3)

0

0 0

0

0

1 (6.3)

Ethnicity, Hispanic or Latino, n (%) 3 (18.8)

7 (22.6)

6 (37.5)

10 (33.3)

Weight, mean (SD), kg BMI, mean (SD), kg/m 2

67.8 (9.9) 25.0 (2.9)

68.2 (12.9)

92.2 (17.5)

87.5 (12.0)

24.6 (4.5)

31.8 (4.6)

32.5 (3.9)

PR-SMFRS, n (%)

Slight amount (1)

6 (37.5)

15 (48.4) 13 (41.9)

0

0

Moderate amount (2)

10 (62.5)

2 (12.5) 8 (50.0) 6 (37.5)

5 (16.7)

Large amount (3)

0 0

2 (6.5) 1 (3.2)

17 (56.7)

Very large amount (4)

8 (26.7)

Fitzpatrick skin type, n (%) I–III

8 (50.0) 8 (50.0)

15 (48.4) 16 (51.6)

9 (56.3) 7 (43.8)

15 (50.0) 15 (50.0)

IV–VI

Skin laxity, n (%)

None (1)/mild (2)

14 (87.5)

26 (83.9)

12 (75.0)

20 (66.7) 10 (33.3)

Moderate (3)/severe (4)

2 (12.5)

5 (16.1)

4 (25.0)

*Mild or extreme SMF defined as a grade of 1 or 4, respectively, on the Clinician-Reported SMF Rating Scale at baseline. BMI, body mass index; PR-SMFRS, Patient-Reported SMF Rating Scale; SMF, submental fat.

the FACE-Q were analyzed as continuous variables using an analysis of covariance model that included treatment, baseline score, baseline SMF severity, and their interactions with treatment.

Treatment Characteristics

The mean (SD) number of ATX-101 treatments received was 4.2 (1.7) and 4.9 (1.6) for subjects with mild and extreme SMF, respectively. A lower per- centage of subjects treated with ATX-101 compared with placebo completed 6 treatments in both the mild SMF (29.0% ATX-101; 50.0% placebo) and extreme SMF (63.3% ATX-101; 87.5% placebo) groups. Among ATX-101 – treated subjects with mild SMF, 72.7% received <6 treatments because of ef fi cacy. The total mean (SD) volume of ATX-101 and pla- cebo administered across all treatments was 22.6 (12.9) and 27.8 (13.7) mL, respectively. Subjects with mild SMF received a lower total mean volume (13.9-mL ATX-101; 17.2-mL placebo) compared with subjects with extreme SMF (31.6-mL ATX-101; 38.4-mL placebo). Mean ATX-101 volume declined over time (from 3.9 mL [ fi rst

Results

Subject Disposition and Baseline Characteristics

Overall, 93 subjects were randomized (ATX-101: n = 61; placebo: n = 32) and strati fi ed by baseline SMF severity (mild: n = 47; extreme; n = 46). Eighty-nine subjects (95.7%) completed the study (Figure 1). Table 1 reports demographic and baseline character- istics. Across all groups, 84.9%of subjects were white, 83.9% were female, mean (SD) age was 50.0 (9.3) years, and mean (SD) BMI was 28.4 (5.5) kg/m 2 . Subjects with mild SMF were, on average, younger and had a lower BMI than those with extreme SMF. All Fitzpatrick skin types were represented.

DE RMATOLOG I C S URG E RY

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