Submental Fullness
Conditions
Brief summary
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.
Interventions
DRUGDeoxycholic acid
Deoxycholic acid (ATX-101) injection as the treatment of SMF as per standard of care in clinical practice.
PROCEDURESurgical Procedures
Surgical procedures for treatment of SMF as per standard of care in clinical practice.
PROCEDURELaser Liposuction
Laser Liposuction for the treatment of SMF as per standard of care in clinical practice..
DEVICEEnergy Devices
Energy Devices for the treatment of SMF as per standard of care in clinical practice.
OTHEROther Treatments
Other treatments for SMF as per standard of care in clinical practice.
Sponsors
Kythera Biopharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Participants 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. | 1,029 |
| Total | 1,029 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patient Decision | 59 |
| Overall Study | Patient Lost to Follow-Up | 137 |
| Overall Study | Patients Not Treated/No EOT Visit | 249 |
| Overall Study | Study Ended by Sponsor | 80 |
Baseline characteristics
| Characteristic | All Enrolled Participants |
|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 12.3 |
| Age, Customized 18 to 30 years | 81 participants |
| Age, Customized 31 to 50 years | 427 participants |
| Age, Customized 51 to 65 years | 413 participants |
| Age, Customized >65 years | 108 participants |
| Sex: Female, Male Female | 883 Participants |
| Sex: Female, Male Male | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 75 / 570 | 2 / 23 | 1 / 5 | 4 / 77 | 2 / 9 | 81 / 676 |
| serious Total, serious adverse events | 0 / 570 | 0 / 23 | 0 / 5 | 0 / 77 | 0 / 9 | 0 / 676 |
Outcome results
Primary
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.
Time frame: Up to 19 Months
Population: Safety Population included all participants who received at least one treatment. Participants may have received more than one treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deoxycholic Acid (ATX-101) | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | 13.2 percentage of participants |
| Surgical | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | 8.7 percentage of participants |
| Laser Liposuction | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | 20.0 percentage of participants |
| Energy Devices | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | 5.2 percentage of participants |
| Other Treatments | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | 22.2 percentage of participants |
Secondary
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.
Time frame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)
Population: Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid (ATX-101) | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change to Follow-up Visit | -0.3 score on a scale | Standard Deviation 0.7 |
| Deoxycholic Acid (ATX-101) | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Baseline | 2.0 score on a scale | Standard Deviation 0.7 |
| Deoxycholic Acid (ATX-101) | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change to EOT Visit | -0.7 score on a scale | Standard Deviation 0.8 |
| Surgical | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change to Follow-up Visit | -1.5 score on a scale | Standard Deviation 0.9 |
| Surgical | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Baseline | 2.5 score on a scale | Standard Deviation 0.7 |
| Surgical | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change to EOT Visit | -1.6 score on a scale | Standard Deviation 0.9 |
| Laser Liposuction | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change to Follow-up Visit | -2.2 score on a scale | Standard Deviation 1.1 |
| Laser Liposuction | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Baseline | 3.2 score on a scale | Standard Deviation 0.8 |
| Laser Liposuction | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change to EOT Visit | -2.0 score on a scale | Standard Deviation 0 |
| Energy Devices | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change to Follow-up Visit | -0.5 score on a scale | Standard Deviation 0.8 |
| Energy Devices | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Baseline | 1.8 score on a scale | Standard Deviation 0.7 |
| Energy Devices | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change to EOT Visit | -0.8 score on a scale | Standard Deviation 0.9 |
| Other Treatments | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change to Follow-up Visit | -0.8 score on a scale | Standard Deviation 0.8 |
| Other Treatments | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Baseline | 2.0 score on a scale | Standard Deviation 0.9 |
| Other Treatments | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change to EOT Visit | -0.5 score on a scale | Standard Deviation 0.6 |
| Not Elected Treatment | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Baseline | 2.0 score on a scale | Standard Deviation 0.7 |
| Not Elected Treatment | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change to EOT Visit | -0.7 score on a scale | Standard Deviation 0.8 |
| Not Elected Treatment | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change to Follow-up Visit | -0.4 score on a scale | Standard Deviation 0.8 |
Secondary
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.
Time frame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment (EOT) Visit (Up to 18 Months)
Population: Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change to Follow-up Visit | -0.4 score on a scale | Standard Deviation 0.7 |
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Baseline | 2.0 score on a scale | Standard Deviation 0.8 |
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change to EOT Visit | -0.8 score on a scale | Standard Deviation 0.8 |
| Surgical | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change to Follow-up Visit | -1.6 score on a scale | Standard Deviation 1.1 |
| Surgical | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Baseline | 2.7 score on a scale | Standard Deviation 0.8 |
| Surgical | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change to EOT Visit | -2.1 score on a scale | Standard Deviation 1 |
| Laser Liposuction | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change to Follow-up Visit | -2.0 score on a scale | Standard Deviation 1 |
| Laser Liposuction | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Baseline | 3.2 score on a scale | Standard Deviation 0.8 |
| Laser Liposuction | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change to EOT Visit | -2.5 score on a scale | Standard Deviation 0.7 |
| Energy Devices | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change to Follow-up Visit | -0.7 score on a scale | Standard Deviation 0.7 |
| Energy Devices | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Baseline | 1.7 score on a scale | Standard Deviation 0.8 |
| Energy Devices | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change to EOT Visit | -0.9 score on a scale | Standard Deviation 1 |
| Other Treatments | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change to Follow-up Visit | -0.4 score on a scale | Standard Deviation 0.6 |
| Other Treatments | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Baseline | 1.8 score on a scale | Standard Deviation 1.1 |
| Other Treatments | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change to EOT Visit | -0.2 score on a scale | Standard Deviation 0.5 |
| Not Elected Treatment | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Baseline | 2.0 score on a scale | Standard Deviation 0.8 |
| Not Elected Treatment | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change to EOT Visit | -0.8 score on a scale | Standard Deviation 0.9 |
| Not Elected Treatment | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change to Follow-up Visit | -0.5 score on a scale | Standard Deviation 0.8 |
Secondary
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.
Time frame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)
Population: Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Change to Follow-up Visit | -1.2 score on a scale | Standard Deviation 1.9 |
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Baseline | 6.9 score on a scale | Standard Deviation 1.8 |
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Change to EOT Visit | -2.8 score on a scale | Standard Deviation 2.6 |
| Surgical | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Change to Follow-up Visit | -4.6 score on a scale | Standard Deviation 2.3 |
| Surgical | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Baseline | 7.9 score on a scale | Standard Deviation 1.5 |
| Surgical | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Change to EOT Visit | -5.4 score on a scale | Standard Deviation 2.6 |
| Laser Liposuction | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Change to Follow-up Visit | -6.6 score on a scale | Standard Deviation 2.7 |
| Laser Liposuction | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Baseline | 9.0 score on a scale | Standard Deviation 0 |
| Laser Liposuction | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Change to EOT Visit | -6.5 score on a scale | Standard Deviation 2.1 |
| Energy Devices | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Change to Follow-up Visit | -1.8 score on a scale | Standard Deviation 2.4 |
| Energy Devices | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Baseline | 6.2 score on a scale | Standard Deviation 2.2 |
| Energy Devices | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Change to EOT Visit | -2.4 score on a scale | Standard Deviation 2.7 |
| Other Treatments | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Change to Follow-up Visit | -2.4 score on a scale | Standard Deviation 2.1 |
| Other Treatments | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Baseline | 7.0 score on a scale | Standard Deviation 2.4 |
| Other Treatments | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Change to EOT Visit | -2.3 score on a scale | Standard Deviation 1.3 |
| Not Elected Treatment | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Baseline | 6.9 score on a scale | Standard Deviation 1.9 |
| Not Elected Treatment | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Change to EOT Visit | -2.9 score on a scale | Standard Deviation 2.7 |
| Not Elected Treatment | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Change to Follow-up Visit | -1.5 score on a scale | Standard Deviation 2.2 |
Secondary
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.
Time frame: Baseline (Day 1) to End of Treatment Visit (Up to 18 Months)
Population: Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Patient Self-Perception of Age (SPA) | Baseline | -1.4 years | Standard Deviation 5 |
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Patient Self-Perception of Age (SPA) | Change to EOT Visit | -1.5 years | Standard Deviation 5.3 |
| Surgical | Change From Baseline in the Patient Self-Perception of Age (SPA) | Baseline | 0.5 years | Standard Deviation 4.3 |
| Surgical | Change From Baseline in the Patient Self-Perception of Age (SPA) | Change to EOT Visit | -5.6 years | Standard Deviation 6.2 |
| Laser Liposuction | Change From Baseline in the Patient Self-Perception of Age (SPA) | Baseline | 3.0 years | Standard Deviation 6.7 |
| Laser Liposuction | Change From Baseline in the Patient Self-Perception of Age (SPA) | Change to EOT Visit | -10.0 years | Standard Deviation 0 |
| Energy Devices | Change From Baseline in the Patient Self-Perception of Age (SPA) | Baseline | -0.5 years | Standard Deviation 4.1 |
| Energy Devices | Change From Baseline in the Patient Self-Perception of Age (SPA) | Change to EOT Visit | -0.6 years | Standard Deviation 3.1 |
| Other Treatments | Change From Baseline in the Patient Self-Perception of Age (SPA) | Baseline | -0.6 years | Standard Deviation 3.2 |
| Other Treatments | Change From Baseline in the Patient Self-Perception of Age (SPA) | Change to EOT Visit | -0.8 years | Standard Deviation 4.4 |
| Not Elected Treatment | Change From Baseline in the Patient Self-Perception of Age (SPA) | Baseline | -1.2 years | Standard Deviation 4.9 |
| Not Elected Treatment | Change From Baseline in the Patient Self-Perception of Age (SPA) | Change to EOT Visit | -1.6 years | Standard Deviation 5.3 |
Secondary
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.
Time frame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)
Population: Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Subject Self Rating Scale (SSRS) | Change to Follow-up Visit | 1.0 score on a scale | Standard Deviation 1.7 |
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Subject Self Rating Scale (SSRS) | Baseline | 2.3 score on a scale | Standard Deviation 1.4 |
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Subject Self Rating Scale (SSRS) | Change to EOT | 2.0 score on a scale | Standard Deviation 2 |
| Surgical | Change From Baseline in the Subject Self Rating Scale (SSRS) | Change to Follow-up Visit | 2.4 score on a scale | Standard Deviation 1.9 |
| Surgical | Change From Baseline in the Subject Self Rating Scale (SSRS) | Baseline | 2.0 score on a scale | Standard Deviation 1.6 |
| Surgical | Change From Baseline in the Subject Self Rating Scale (SSRS) | Change to EOT | 2.8 score on a scale | Standard Deviation 2.3 |
| Laser Liposuction | Change From Baseline in the Subject Self Rating Scale (SSRS) | Change to Follow-up Visit | 3.6 score on a scale | Standard Deviation 2.1 |
| Laser Liposuction | Change From Baseline in the Subject Self Rating Scale (SSRS) | Baseline | 1.4 score on a scale | Standard Deviation 1.5 |
| Laser Liposuction | Change From Baseline in the Subject Self Rating Scale (SSRS) | Change to EOT | 4.5 score on a scale | Standard Deviation 2.1 |
| Energy Devices | Change From Baseline in the Subject Self Rating Scale (SSRS) | Change to Follow-up Visit | 1.6 score on a scale | Standard Deviation 1.8 |
| Energy Devices | Change From Baseline in the Subject Self Rating Scale (SSRS) | Baseline | 2.1 score on a scale | Standard Deviation 1.4 |
| Energy Devices | Change From Baseline in the Subject Self Rating Scale (SSRS) | Change to EOT | 2.1 score on a scale | Standard Deviation 1.9 |
| Other Treatments | Change From Baseline in the Subject Self Rating Scale (SSRS) | Change to Follow-up Visit | 1.2 score on a scale | Standard Deviation 2.2 |
| Other Treatments | Change From Baseline in the Subject Self Rating Scale (SSRS) | Baseline | 2.6 score on a scale | Standard Deviation 1.2 |
| Other Treatments | Change From Baseline in the Subject Self Rating Scale (SSRS) | Change to EOT | 1.3 score on a scale | Standard Deviation 1.5 |
| Not Elected Treatment | Change From Baseline in the Subject Self Rating Scale (SSRS) | Baseline | 2.2 score on a scale | Standard Deviation 1.4 |
| Not Elected Treatment | Change From Baseline in the Subject Self Rating Scale (SSRS) | Change to EOT | 2.1 score on a scale | Standard Deviation 2 |
| Not Elected Treatment | Change From Baseline in the Subject Self Rating Scale (SSRS) | Change to Follow-up Visit | 1.1 score on a scale | Standard Deviation 1.8 |
Secondary
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.
Time frame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)
Population: Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Change to Follow-up Visit | -0.1 score on a scale | Standard Deviation 0.7 |
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Baseline | 2.0 score on a scale | Standard Deviation 0.8 |
| Deoxycholic Acid (ATX-101) | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Change to EOT Visit | -0.2 score on a scale | Standard Deviation 0.7 |
| Surgical | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Change to Follow-up Visit | -0.6 score on a scale | Standard Deviation 1 |
| Surgical | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Baseline | 2.2 score on a scale | Standard Deviation 0.7 |
| Surgical | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Change to EOT Visit | -0.6 score on a scale | Standard Deviation 1 |
| Laser Liposuction | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Change to Follow-up Visit | -0.4 score on a scale | Standard Deviation 1.1 |
| Laser Liposuction | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Baseline | 2.0 score on a scale | Standard Deviation 0.7 |
| Laser Liposuction | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Change to EOT Visit | -0.5 score on a scale | Standard Deviation 0.7 |
| Energy Devices | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Change to Follow-up Visit | -0.4 score on a scale | Standard Deviation 0.6 |
| Energy Devices | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Baseline | 2.1 score on a scale | Standard Deviation 0.8 |
| Energy Devices | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Change to EOT Visit | -0.3 score on a scale | Standard Deviation 0.6 |
| Other Treatments | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Change to Follow-up Visit | -0.4 score on a scale | Standard Deviation 0.6 |
| Other Treatments | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Baseline | 2.0 score on a scale | Standard Deviation 0.7 |
| Other Treatments | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Change to EOT Visit | -0.2 score on a scale | Standard Deviation 0.5 |
| Not Elected Treatment | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Baseline | 2.0 score on a scale | Standard Deviation 0.8 |
| Not Elected Treatment | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Change to EOT Visit | -0.3 score on a scale | Standard Deviation 0.7 |
| Not Elected Treatment | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | Change to Follow-up Visit | -0.2 score on a scale | Standard Deviation 0.7 |