April 2020 HSC Section 4 - Plastic and Reconstructive Problems

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

Figure 3. Representative before/after treatment photographs. (A) A 30-year-old female subject with mild SMF who received 4 ATX-101 treatments (11.6 mL) and (B) a 49-year-old male subject with extreme SMF who received 2 ATX-101 treatments (13.4 mL). *Skin laxity assessed by the clinician according to the SMSLG scale. BMI, body mass index; CR-SMFRS, Clinician- Reported SMF Rating Scale; PR-SMFIS, Patient-Reported SMF Impact Scale; PR-SMFRS, Patient-Reported SMF Rating Scale; SMF, submental fat; SMSLG, Submental Skin Laxity Grade; SSRS, Subject Self-Rating Scale; TSS, total scale score.

severity ( p < .01; Table 2). Subjects treated with ATX- 101 also perceived signi fi cantly greater reductions in SMF based on line drawing assessments compared with subjects treated with placebo ( p < .05). ATX- 101 – treated subjects reported greater improvement over placebo-treated subjects in self-ratings of attrac- tiveness of the chin/neck ( p < .005), and higher per- centages were SGQ responders in both SMF severity groups. Results from the FACE-Q indicate that ATX- 101 – treated subjects were more satis fi ed with their results compared with placebo-treated subjects, regardless of baseline SMF severity.

(95.1% for ATX-101 vs 78.1% for placebo), and their incidence decreased after the fi rst treatment. Two serious AEs were reported: recurrence of uterine can- cer (not related to treatment; subject with extreme SMF who discontinued from the study after 4 ATX-101 treatments) and osteoarthritis (not related to treatment; subject withmild SMFwho continued ATX- 101 treatment). Eight ATX-101 – treated subjects received <6 treatments because of AEs (Figure 1). The median duration ofmost commonAEswas # 16 days in the ATX-101 groups and <8 days in the placebo groups, including the injection site AEs of pain, edema, bruising, erythema, and paresthesia (Table 3). Two events of marginal mandibular nerve paresis were reported, both in ATX-101 – treated subjects with mild SMF. Both events resolved (mild event after

Safety

Adverse events were primarily mild or moderate (Table 3). Most AEs were localized to the injection site

DE RMATOLOG I C S URG E RY

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