Condition of Submental Fullness and Treatment Outcomes Registry

An adverse event is any undesirable medical occurrence or worsening of an existing condition that occurs after SMF reduction treatment, irrespective of whether the event is considered treatment related. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving treatment.

The CR-SMFRS is based on the investigator's clinical evaluation of the participant's chin and neck area using a 5-point ordinal scale (0 to 4) with 0=Absent Submental Convexity: no localized submental fat evident; 1=Mild Submental Convexity: minimal, localized submental fat; 2=Moderate Submental Convexity: prominent, localized submental fat; 3=Severe Submental Convexity; a marked amount of chin fat; and 4=Extreme Submental Convexity: marked, localized submental fat. A negative change from Baseline indicates improvement.

The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0 to 4) with 0=No chin fat at all, 1=A slight amount of chin fat, 2=A moderate amount of chin fat, 3=A large amount of chin fat, and 4=A very large amount of chin fat. A negative change from Baseline indicates improvement.

The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.

The participant was asked to answer the question: "Considering your appearance in association with your face and chin, how satisfied do you feel with your appearance at the present time?" using a 7-point scale: 0=Extremely dissatisfied, 1=Dissatisfied, 2=Slightly dissatisfied, 3=neither satisfied nor dissatisfied, 4=Slightly satisfied, 5=Satisfied, and 6=Extremely satisfied. A positive change from Baseline indicates improvement.

The participant rated their facial age in years at Baseline and at the End of Treatment Visit by answering the question: How many years difference compare to your actual age? A negative number indicates younger and a positive number indicates older. A negative change from Baseline indicates an improvement.

SMSLG assessment was based on clinical evaluation and palpation of the submental area. The SMSLG scale incorporates 3 features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds).

Grade 1 (none): no or minimal superficial wrinkling, skin well apposed to deeper neck structures, no skin redundancy [no skin draping or skin sagging]; Grade 2 (mild): mild superficial wrinkling, skin well apposed to deeper neck structures, minimal skin redundancy [slight skin draping and sagging]; Grade 3 (moderate): may have mild to moderate superficial wrinkling, skin has mild to moderate separation from deeper neck structures, moderate skin redundancy [moderate skin draping and skin sagging]; Grade 4 (severe): mild to marked superficial wrinkling, loose skin separated from deeper neck structures, marked skin redundancy [marked skin draping and sagging]. A negative change from Baseline indicates improvement.