April 2020 HSC Section 4 - Plastic and Reconstructive Problems

G LOGAU E T A L

both clinician and subject assessment (composite CR-1/PR-1 response). Among subjects with extreme SMF at baseline, achievement of a $ 2-grade improvement in SMF from baseline was also evaluated (CR-2, PR-2, and composite CR-2/PR-2 response). Responder analyses included the SSRS and Subject Global Questions (SGQ). 8,9 Mean change from baseline in the psychological impact of SMF (assessed using the validated Patient-Reported SMF Impact Scale [PR-SMFIS] total scale score [TSS]), 8,9,13 SMF thickness (measured with cali- pers), subject perception of reduction in SMF (using standardized line drawings of submental convex- ity), 8,9 and self-ratings of attractiveness of the chin/neck area were also evaluated. Scales of the FACE-Q Satisfaction with Facial Appearance questionnaire 14 – 16 relevant to the submental area were used. Standardized photography was per- formed at baseline and 12 weeks after last treatment.

Adverse events (AEs) were monitored throughout the study. Safety was additionally evaluated through examination of the submental area, clinical laboratory tests, vital signs, body weight, and physical examina- tions. Clinicians graded skin laxity using the Sub- mental Skin Laxity Grade scale. 8,9 Sample size was based primarily on clinical consid- erations to allow for suf fi cient analysis of safety. However, a sample size of 30 subjects per treatment group provided approximately 80%power to detect a treatment difference at the 0.05 alpha level. Outcomes were analyzed for the intent-to-treat pop- ulation, which comprised all randomized subjects. Covariate effects were examined using analysis of covariance and logistic regression. For responder analyses, a Cochran – Mantel – Haenszel test strati fi ed by baseline SMF severity was performed. All scales of Statistical Analysis

Figure 1. Subject disposition by randomization and baseline SMF severity. Completed study was defined as completing the visit at 12 weeks after last treatment. *AEs among ATX-101–treated subjects with mild SMF who received <6 treatments included anesthesia (numbness) and swelling (received 1 treatment); anesthesia (numbness), swelling, and pain (received 1 treatment); and ulceration (received 2 treatments). †AEs among ATX-101–treated subjects with extreme SMF who received <6 treatments included bruising (received 1 treatment); bruising, edema, and pain (received 2 treatments); swelling, ten- derness, and pain (received 2 treatments); anesthesia (numbness), bruising, and swelling (received 4 treatments); and lymphadenopathy and uterine cancer (received 4 treatments). AE, adverse event; SMF, submental fat.

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