April 2020 HSC Section 4 - Plastic and Reconstructive Problems

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

TABLE 2. Efficacy Outcomes at 12 Weeks After Last Treatment

Mild SMF,* n = 47

Extreme SMF,* n = 46

ATX- 101, n = 31

ATX- 101, n = 30

Placebo, n = 16

Placebo, n = 16

p

p

2 1.1 (0.7) 2 3.5 (0.5) .006 2 1.3 (0.9) 2 6.9 (0.6) <.001

SMF thickness, LS mean (SE) change from baseline

SGQ responders, n (%)† Fat under chin

3 (20.0) 3 (20.0) 4 (26.7)

22 (71.0) .001 0 (0) 19 (61.3) .009 0 (0) 23 (74.2) .002 4 (26.7)

21 (75.0) <.001 21 (75.0) <.001 23 (82.1) <.001

Definition between chin and neck

Satisfied with treatment

2 0.6 (0.2) 2 1.2 (0.2) .046 2 0.5 (0.3) 2 1.4 (0.2) .020

Subject perception of SMF reduction using line drawing assessment, LS mean (SE) change from baseline Self-ratings of attractiveness of chin/neck area, LS mean (SE) change from baseline ‡

0.9 (0.5)

3.1 (0.4)

.002 0.5 (0.5)

3.5 (0.4) <.001

FACE-Q x ║ Satisfaction with outcome, mean score Satisfaction with decision, mean score

31.2 43.8 13.4

62.8 <.001 16.1 67.8 .010 32.3 35.3 .019 9.7

60.7 <.001 72.9 <.001 46.3 <.001

Appraisal of area under chin, LS mean change from baseline Satisfaction with lower face and jawline, LS mean change from baseline Appraisal of neck, LS mean change from baseline Satisfaction with chin, LS mean change from baseline Aging appearance appraisal, LS mean change from baseline Satisfaction with facial appearance, LS mean change from baseline Psychological well-being, LS mean change from baseline

15.1

31.9 .031 2.1

33.3 <.001

10.3

22.9 .071 3.7 17.0 .114 2.0

34.2 <.001 27.1 <.001 20.3 <.001

6.0 1.9

2 5.2

17.6 .035

10.3

13.5 .598 5.8

26.4 .008

9.4

13.0 .581 3.6

14.8 .074

2 1.2

2 1.8 .424 1.0

2 3.9 .002

Age appraisal by VAS, LS mean

*Mild or extreme SMF defined as a grade of 1 or 4, respectively, on the Clinician-Reported SMF Rating Scale at baseline. †SGQ responders defined as subjects who rated the first 2 questions as moderately better or a great deal better and the third question as moderately satisfied or extremely satisfied. Percentage based on the number of responses to each question. ‡Rated on a 10-point scale from 1 (not at all attractive) to 9 (extremely attractive). x The first 9 scales scored per the questionnaire developer’s proprietary algorithm for individual item weights and scaled from 0 to 100 using a Rasch transformation. Higher values are associated with positive outcomes. VAS age appraisal scored from 2 15 to 15 and not transformed. ║ Validated scale. LS, least squares; SGQ, Subject Global Questions; SMF, submental fat; VAS, visual analog scale.

4 days; moderate event after 52 days), and both sub- jects received additional treatment. Mild dysphagia, which resolved after 2 days, was reported in an ATX- 101 – treated subject with extreme SMF who went on to receive additional treatment. One event of skin ulceration, which resolved within 63 days, occurred in an ATX-101 – treated subject with mild SMF.

unchanged or improved from baseline in 93.3% of placebo-treated subjects with extreme SMF and in 100% of subjects in the remaining 3 groups. No clin- ically meaningful changes in laboratory tests, vital signs, or physical examinations were seen.

Discussion

This study evaluated the safety and ef fi cacy of ATX-101 in the previously unstudied populations of subjects with mild or extreme SMF. Overall, the results obtained in this trial are consistent with those in the

No signi fi cant changes in skin laxity were observed over the course of the study, regardless of baseline SMF severity or treatment (Figure 5). Skin laxity was

DE RMATOLOG I C S URG E RY

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