Condition of Submental Fullness and Treatment Outcomes Registry

Study Overview
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Brief Summary
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The primary objective of this registry is to develop a comprehensive understanding of the condition of submental (SM) fullness due to submental fat (SMF), how it is treated in current clinical practice, and the risks and benefits associated with its treatment.

Official Title
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CONTOUR: Condition of Submental Fullness and Treatment Outcomes Registry (A Registry of Submental Fullness, Treatment Options Administered, and Associated Outcomes)

Conditions
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Submental Fullness

Intervention / Treatment
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* Drug: Deoxycholic acid
* Procedure: Surgical Procedures
* Procedure: Laser Liposuction
* Device: Energy Devices
* Other: Other Treatments


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Enrolled Participants<br>All enrolled participants who signed informed consent whether or not they elected to receive treatment as per standard of care in clinical practice for submental fat (SMF). Treatments for SMF included: ATX1-101, Surgical Procedures, Laser Liposuction, Energy Devices or Other Treatments. | Drug: Deoxycholic acid<br>* Deoxycholic acid (ATX-101) injection as the treatment of SMF as per standard of care in clinical practice.<br>* Other names: KYBELLA;Procedure: Surgical Procedures<br>* Surgical procedures for treatment of SMF as per standard of care in clinical practice.<br>Procedure: Laser Liposuction<br>* Laser Liposuction for the treatment of SMF as per standard of care in clinical practice..<br>Device: Energy Devices<br>* Energy Devices for the treatment of SMF as per standard of care in clinical practice.<br>Other: Other Treatments<br>* Other treatments for SMF as per standard of care in clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | 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. | Up to 19 Months | 

Secondary Outcome Measures

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