Condition of Submental Fullness and Treatment Outcomes Registry

• Deoxycholic acid (Drug), also known as ATX-101, KYBELLA: Deoxycholic acid (ATX-101) injection as the treatment of SMF as per standard of care in clinical practice.
• Surgical Procedures (Procedure): Surgical procedures for treatment of SMF as per standard of care in clinical practice.
• Laser Liposuction (Procedure): Laser Liposuction for the treatment of SMF as per standard of care in clinical practice..
• Energy Devices (Device): Energy Devices for the treatment of SMF as per standard of care in clinical practice.
• Other Treatments (Other): Other treatments for SMF as per standard of care in clinical practice.

Primary outcomes

• Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) [Up to 19 Months]: 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.

Secondary outcomes

• Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) [Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment (EOT) Visit (Up to 18 Months)]: 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.
• Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) [Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)]: 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.
• Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) [Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)]: 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.
• Change From Baseline in the Subject Self Rating Scale (SSRS) [Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)]: 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.
• Change From Baseline in the Patient Self-Perception of Age (SPA) [Baseline (Day 1) to End of Treatment Visit (Up to 18 Months)]: 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.
• Change From Baseline in the Submental Skin Laxity Scale (SMSLG) [Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)]: 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.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Adult male and female patients, aged 18 years and above, presenting with SM fullness due to the accumulation of unwanted SMF, and considered by their treating physician to be a candidate to receive treatment of SM fullness by reduction of SMF, if the patient decides
* Signed informed consent by the patient, obtained before any study-related activities are undertaken
* Willing to complete all patient assessment questionnaires
* Signed release form by the patient, permitting abstraction of the patient's medical records at baseline and during participation in the registry

Exclusion Criteria:

* Severe skin laxity, defined as superficial wrinkling, loose skin separated from deeper neck structures, and/or marked skin redundancy (draping and/or sagging), per the physician's judgment
* Any other cause of fullness in the SM area (eg, thyroid enlargement, cervical adenopathy) other than localized SMF
* Participating in an interventional clinical study, currently or within 30 days before enrollment

Participant flow

Outcome results

• Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) (Primary), Number, percentage of participants: Deoxycholic Acid (ATX-101) 13.2; Surgical 8.7; Laser Liposuction 20.0; Energy Devices 5.2; Other Treatments 22.2
• Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) (Secondary), Mean, score on a scale: Deoxycholic Acid (ATX-101) 2.0 +/- 0.8; Surgical 2.7 +/- 0.8; Laser Liposuction 3.2 +/- 0.8; Energy Devices 1.7 +/- 0.8; Other Treatments 1.8 +/- 1.1; Not Elected Treatment 2.0 +/- 0.8
• Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) (Secondary), Mean, score on a scale: Deoxycholic Acid (ATX-101) 2.0 +/- 0.7; Surgical 2.5 +/- 0.7; Laser Liposuction 3.2 +/- 0.8; Energy Devices 1.8 +/- 0.7; Other Treatments 2.0 +/- 0.9; Not Elected Treatment 2.0 +/- 0.7
• Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) (Secondary), Mean, score on a scale: Deoxycholic Acid (ATX-101) 6.9 +/- 1.8; Surgical 7.9 +/- 1.5; Laser Liposuction 9.0 +/- 0.0; Energy Devices 6.2 +/- 2.2; Other Treatments 7.0 +/- 2.4; Not Elected Treatment 6.9 +/- 1.9
• Change From Baseline in the Subject Self Rating Scale (SSRS) (Secondary), Mean, score on a scale: Deoxycholic Acid (ATX-101) 2.3 +/- 1.4; Surgical 2.0 +/- 1.6; Laser Liposuction 1.4 +/- 1.5; Energy Devices 2.1 +/- 1.4; Other Treatments 2.6 +/- 1.2; Not Elected Treatment 2.2 +/- 1.4
• Change From Baseline in the Patient Self-Perception of Age (SPA) (Secondary), Mean, years: Deoxycholic Acid (ATX-101) -1.4 +/- 5.0; Surgical 0.5 +/- 4.3; Laser Liposuction 3.0 +/- 6.7; Energy Devices -0.5 +/- 4.1; Other Treatments -0.6 +/- 3.2; Not Elected Treatment -1.2 +/- 4.9
• Change From Baseline in the Submental Skin Laxity Scale (SMSLG) (Secondary), Mean, score on a scale: Deoxycholic Acid (ATX-101) 2.0 +/- 0.8; Surgical 2.2 +/- 0.7; Laser Liposuction 2.0 +/- 0.7; Energy Devices 2.1 +/- 0.8; Other Treatments 2.0 +/- 0.7; Not Elected Treatment 2.0 +/- 0.8

Adverse events

Time frame: Up to 19 Months

Other adverse events by term

• Results publication: Palm MD, Schlessinger J, Callender VD, Fagien S, Beer K, Magante S, Sangha S. Final Data from the Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR). J Drugs Dermatol. 2019 Jan 1;18(1):40-48. PMID 30681793

• Rina Patel, MS, CCRA, Study director, Allergan