Moderate or Severe Submental Fullness
Conditions
Brief summary
To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area (below the chin).
Interventions
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Sponsors
Kythera Biopharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Submental fat graded by the investigator as 2, 3, or 4 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2, 3, or 4 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on visit 1 (within 28 days before the subject's first dosing session) * Dissatisfaction with the submental area rated by the subject as 0, 1, or 2 using the Subject Self-rating Scale (SSRS) as determined on visit 1 (within 28 days before the subject's first dosing session) * Males and nonpregnant, nonlactating females 18 years of age or greater, on the day of the subject's first dosing session (visit 2). Females of childbearing potential must have a negative human chorionic gonadotropin (serum) test result within 28 days before visit 2 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study * A normal result on coagulation tests (prothrombin time (PT), partial thromboplastin time (PTT)) obtained within 28 days before subject's first dosing session * History of stable body weight, in the judgment of the investigator, for at least 6 months before subject's first dosing session * Expected to understand and comply with the visit schedule and all protocol-specified tests and procedures and agreement by the subject to refrain from making significant changes, in the judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation * Medically able to undergo the administration of study drug determined by clinical and laboratory tests obtained within 28 days before subject's first dosing session for which the investigator identifies no clinically significant abnormality * Signed informed consent obtained before any study-specific procedure is performed
Exclusion criteria
* History of any intervention to treat submental fat (eg, liposuction, surgery, or lipolytic agents) * History of trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment * A grade of 4 on the Submental Skin Laxity Grading scale (SMSLG) or any other anatomical feature (eg, predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands) for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome * Evidence of any cause of enlargement in the submental area (eg, thyroid enlargement, cervical adenopathy) other than localized submental fat * Body mass index of ≥ 40 kg/m² as determined on visit 1 (week 0) * History or current symptoms of dysphagia * Any medical condition that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent * Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before the first treatment session, or botulinum toxin injections in the neck or chin area within 6 months before the first treatment session * History of sensitivity to any components of the study drug or to topical or local anesthetics (eg, lidocaine, benzocaine, novocaine) * Previous treatment in this study or previous participation in a Kythera-sponsored ATX-101 study * Treatment with an investigational device or agent within 30 days before the subject's first treatment session
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 12 months after last treatment (maximum of 18 months from first treatment) | Serious AEs include any event that met one or more of the following criteria: was fatal or life-threatening, required inpatient hospitalization or prolonged a hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or a significant medical hazard. The severity of each AE was defined as either: Mild: The participant was aware of the sign or symptom, but it was easily tolerated. Moderate: The sign or symptom caused discomfort and interfered with usual activity. Severe: The sign or symptom was incapacitating, and the participant was unable to engage in usual activity. The investigator determined the relationship of each AE to the study drug using the question: Is there a reasonable possibility that the event may have been caused by treatment with the study drug? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS) | Baseline and month 3 and month 12 after last treatment | The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (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. |
| Percentage of Participants Who Achieved a Composite 1-grade Response | Baseline and month 3 and month 12 after last treatment | A composite 1-grade response is defined as at least a 1-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (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). |
| Percentage of Participants Who Achieved a Composite 2-grade Response | Baseline and month 3 and month 12 after last treatment | A composite 2-grade response is defined as at least a 2-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (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). |
| Mean Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Baseline and month 3 and month 12 after last treatment | The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) related to the appearance of submental fullness 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. |
| Mean Change From Baseline in Subject Self Rating Scale (SSRS) | Baseline and month 3 and month 12 after last treatment | The SSRS assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 (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. |
| Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS) | Baseline and months 3, 6, 9, and 12 after last treatment | The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). A negative change from baseline indicates improvement. |
| Response to Subject Global Questions | Month 3 and month 12 after last treatment | Participants answered 3 questions on a 7-point scale that ranged from a great deal worse to a great deal better (questions 1 and 2) or from extremely dissatisfied to extremely satisfied (question 3). Question 1: Since the start of the study, how would you rate the fat under your chin right now? Question 2: Since the start of the study, how would you rate the definition between your chin and neck right now? Question 3: How satisfied are you with the treatment you received in this study? |
| Percent Change From Baseline in Submental Fat Thickness | Baseline and month 3 and month 12 after last treatment | Submental fat thickness was measured using calipers. |
| Change From Baseline in Submental Skin Laxity Grade (SMSLG) | Baseline and month 3 and month 12 after last treatment | 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 (vertical folds) or skin sagging (horizontal folds)); 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). |
| Change From Baseline in Line Drawing Assessment | Baseline and month 3 after last treatment | Each participant was given 2 example line drawings representing each of the 5 submental fat grades (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme) and asked to select the drawing that best represents their current profile. Improvement is any decrease in grade, and worsening is any increase in grade. |
| Mean Change From Baseline in Self-rating of Attractiveness | Baseline and month 3 and month 12 after last treatment | Self-rating of Attractiveness assesses aspects of appearance from the participant's perspective with a series of 6 questions: How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 (1 = not at all attractive, 5 = neither attractive nor unattractive, and 9 = extremely attractive). A positive change from baseline indicates improvement. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 18 investigational centers in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Deoxycholic Acid 2 mg/cm² Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. | 165 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Lost to Follow-up | 14 |
| Overall Study | Miscellaneous Reasons | 4 |
| Overall Study | Participant Convenience | 10 |
Baseline characteristics
| Characteristic | Deoxycholic Acid 2 mg/cm² |
|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 10.89 |
| Age, Customized 18 - 50 years | 98 participants |
| Age, Customized 51 - 65 years | 63 participants |
| Age, Customized > 65 years | 4 participants |
| Body Mass Index (BMI) | 28.88 kg/m² STANDARD_DEVIATION 4.311 |
| Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Rating 2 | 86 participants |
| Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Rating 3 | 66 participants |
| Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Rating 4 | 13 participants |
| Fitzpatrick Skin Type I - III | 123 participants |
| Fitzpatrick Skin Type IV - VI | 42 participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 participants |
| Race/Ethnicity, Customized Asian | 7 participants |
| Race/Ethnicity, Customized Black or African American | 15 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 30 participants |
| Race/Ethnicity, Customized Multiple | 1 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 135 participants |
| Race/Ethnicity, Customized Other | 12 participants |
| Race/Ethnicity, Customized White | 129 participants |
| Sex: Female, Male Female | 128 Participants |
| Sex: Female, Male Male | 37 Participants |
| Weight | 80.37 kg STANDARD_DEVIATION 15.111 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 160 / 165 |
| serious Total, serious adverse events | 7 / 165 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)
Serious AEs include any event that met one or more of the following criteria: was fatal or life-threatening, required inpatient hospitalization or prolonged a hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or a significant medical hazard. The severity of each AE was defined as either: Mild: The participant was aware of the sign or symptom, but it was easily tolerated. Moderate: The sign or symptom caused discomfort and interfered with usual activity. Severe: The sign or symptom was incapacitating, and the participant was unable to engage in usual activity. The investigator determined the relationship of each AE to the study drug using the question: Is there a reasonable possibility that the event may have been caused by treatment with the study drug?
Time frame: Up to 12 months after last treatment (maximum of 18 months from first treatment)
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid 2 mg/cm² | Number of Participants With Adverse Events (AEs) | Adverse event leading to withdrawal from treatment | 15 participants |
| Deoxycholic Acid 2 mg/cm² | Number of Participants With Adverse Events (AEs) | Any adverse event | 160 participants |
| Deoxycholic Acid 2 mg/cm² | Number of Participants With Adverse Events (AEs) | Serious adverse event | 7 participants |
| Deoxycholic Acid 2 mg/cm² | Number of Participants With Adverse Events (AEs) | Severe adverse event | 11 participants |
| Deoxycholic Acid 2 mg/cm² | Number of Participants With Adverse Events (AEs) | Adverse event leading to study discontinuation | 6 participants |
| Deoxycholic Acid 2 mg/cm² | Number of Participants With Adverse Events (AEs) | Adverse event leading to death | 1 participants |
| Deoxycholic Acid 2 mg/cm² | Number of Participants With Adverse Events (AEs) | Adverse event related to study drug | 155 participants |
| Deoxycholic Acid 2 mg/cm² | Number of Participants With Adverse Events (AEs) | Serious adverse event related to study drug | 0 participants |
| Deoxycholic Acid 2 mg/cm² | Number of Participants With Adverse Events (AEs) | Adverse event associated with the treatment area | 158 participants |
Secondary
Change From Baseline in Line Drawing Assessment
Each participant was given 2 example line drawings representing each of the 5 submental fat grades (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme) and asked to select the drawing that best represents their current profile. Improvement is any decrease in grade, and worsening is any increase in grade.
Time frame: Baseline and month 3 after last treatment
Population: Treatment effect population with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid 2 mg/cm² | Change From Baseline in Line Drawing Assessment | Worsened by 1 | 8 participants |
| Deoxycholic Acid 2 mg/cm² | Change From Baseline in Line Drawing Assessment | Improved by 2 | 52 participants |
| Deoxycholic Acid 2 mg/cm² | Change From Baseline in Line Drawing Assessment | Improved by 1 | 25 participants |
| Deoxycholic Acid 2 mg/cm² | Change From Baseline in Line Drawing Assessment | Unchanged | 31 participants |
| Deoxycholic Acid 2 mg/cm² | Change From Baseline in Line Drawing Assessment | Improved by > 2 | 27 participants |
| Deoxycholic Acid 2 mg/cm² | Change From Baseline in Line Drawing Assessment | Worsened by 2 | 0 participants |
| Deoxycholic Acid 2 mg/cm² | Change From Baseline in Line Drawing Assessment | Worsened by > 2 | 0 participants |
Secondary
Change From Baseline in Submental Skin Laxity Grade (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 (vertical folds) or skin sagging (horizontal folds)); 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).
Time frame: Baseline and month 3 and month 12 after last treatment
Population: Treatment effect population with available data (indicated by n)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid 2 mg/cm² | Change From Baseline in Submental Skin Laxity Grade (SMSLG) | Month 3 after last treatment (n = 144) | -0.3 units on a scale | Standard Deviation 0.58 |
| Deoxycholic Acid 2 mg/cm² | Change From Baseline in Submental Skin Laxity Grade (SMSLG) | Month 12 after last treatment (n = 131) | -0.3 units on a scale | Standard Deviation 0.63 |
Secondary
Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS)
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). A negative change from baseline indicates improvement.
Time frame: Baseline and months 3, 6, 9, and 12 after last treatment
Population: Treatment effect population (all participants who received at least 1 injection with study drug and had any posttreatment data for treatment effect variables or for the submental skin laxity grade) and with available data at each time point (indicated by n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS) | Month 3 after last treatment (n = 144) | -1.3 units on a scale | Standard Deviation 0.85 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS) | Month 6 after last treatment (n = 133) | -1.3 units on a scale | Standard Deviation 0.85 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS) | Month 9 after last treatment (n = 134) | -1.4 units on a scale | Standard Deviation 0.81 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS) | Month 12 after last treatment (n = 131) | -1.4 units on a scale | Standard Deviation 0.8 |
Secondary
Mean Change From Baseline in 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 (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) related to the appearance of submental fullness 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 and month 3 and month 12 after last treatment
Population: Treatment effect population with available data at baseline and each time point (indicated by n)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Month 3 after last treatment (n = 145) | -4.3 units on a scale | Standard Deviation 2.86 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Month 12 after last treatment (n = 129) | -4.2 units on a scale | Standard Deviation 2.86 |
Secondary
Mean Change From Baseline in Patient-Reported Submental Fat Scale 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? and answered on a 5-point ordinal scale (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 and month 3 and month 12 after last treatment
Population: Treatment effect population with available data at baseline (163) and at each time point (indicated by n)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS) | Month 3 after last treatment (n = 142) | -1.2 units on a scale | Standard Deviation 0.9 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS) | Month 12 after last treatment (n = 127) | -1.3 units on a scale | Standard Deviation 0.88 |
Secondary
Mean Change From Baseline in Self-rating of Attractiveness
Self-rating of Attractiveness assesses aspects of appearance from the participant's perspective with a series of 6 questions: How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 (1 = not at all attractive, 5 = neither attractive nor unattractive, and 9 = extremely attractive). A positive change from baseline indicates improvement.
Time frame: Baseline and month 3 and month 12 after last treatment
Population: Treatment effect population with available data at baseline (163), month 3 (144), and month 12 (130)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Self-rating of Attractiveness | Mouth - month 3 after last treatment | 0.3 units on a scale | Standard Deviation 1.45 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Self-rating of Attractiveness | Overall appearance - month 3 after last treatment | 0.8 units on a scale | Standard Deviation 1.53 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Self-rating of Attractiveness | Overall appearance - month 12 after last treatment | 1.0 units on a scale | Standard Deviation 1.62 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Self-rating of Attractiveness | Chin/neck - month 3 after last treatment | 2.6 units on a scale | Standard Deviation 2.35 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Self-rating of Attractiveness | Chin/neck - month 12 after last treatment | 3.1 units on a scale | Standard Deviation 2.43 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Self-rating of Attractiveness | Eyes - month 3 after last treatment | 0.4 units on a scale | Standard Deviation 1.62 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Self-rating of Attractiveness | Eyes - month 12 after last treatment | 0.6 units on a scale | Standard Deviation 1.7 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Self-rating of Attractiveness | Nose - month 3 after last treatment | 0.3 units on a scale | Standard Deviation 1.66 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Self-rating of Attractiveness | Nose - month 12 after last treatment | 0.6 units on a scale | Standard Deviation 1.97 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Self-rating of Attractiveness | Mouth - month 12 after last treatment | 0.6 units on a scale | Standard Deviation 1.44 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Self-rating of Attractiveness | Entire face - month 3 after last treatment | 0.5 units on a scale | Standard Deviation 1.27 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Self-rating of Attractiveness | Entire face - month 12 after last treatment | 0.8 units on a scale | Standard Deviation 1.28 |
Secondary
Mean Change From Baseline in Subject Self Rating Scale (SSRS)
The SSRS assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 (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 and month 3 and month 12 after last treatment
Population: Treatment effect population with available data (indicated by n)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Subject Self Rating Scale (SSRS) | Month 3 after last treatment (n = 144) | 3.6 units on a scale | Standard Deviation 1.49 |
| Deoxycholic Acid 2 mg/cm² | Mean Change From Baseline in Subject Self Rating Scale (SSRS) | Month 12 after last treatment (n = 128) | 3.8 units on a scale | Standard Deviation 1.36 |
Secondary
Percentage of Participants Who Achieved a Composite 1-grade Response
A composite 1-grade response is defined as at least a 1-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (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).
Time frame: Baseline and month 3 and month 12 after last treatment
Population: Treatment effect population with available data at baseline and at each time point (indicated by n)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid 2 mg/cm² | Percentage of Participants Who Achieved a Composite 1-grade Response | Month 3 after last treatment (n = 142) | 72.5 percentage of participants |
| Deoxycholic Acid 2 mg/cm² | Percentage of Participants Who Achieved a Composite 1-grade Response | Month 12 after last treatment (n = 128) | 75.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved a Composite 2-grade Response
A composite 2-grade response is defined as at least a 2-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (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).
Time frame: Baseline and month 3 and month 12 after last treatment
Population: Treatment effect population with available data at baseline and at each time point (indicated by n)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid 2 mg/cm² | Percentage of Participants Who Achieved a Composite 2-grade Response | Month 3 after last treatment (n = 142) | 14.1 percentage of participants |
| Deoxycholic Acid 2 mg/cm² | Percentage of Participants Who Achieved a Composite 2-grade Response | Month 12 after last treatment (n = 128) | 20.3 percentage of participants |
Secondary
Percent Change From Baseline in Submental Fat Thickness
Submental fat thickness was measured using calipers.
Time frame: Baseline and month 3 and month 12 after last treatment
Population: Treatment effect population with available data at baseline (164) and at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid 2 mg/cm² | Percent Change From Baseline in Submental Fat Thickness | Month 12 after last treatment (n = 131) | -30.9 percent change | Standard Deviation 20.88 |
| Deoxycholic Acid 2 mg/cm² | Percent Change From Baseline in Submental Fat Thickness | Month 3 after last treatment (n = 144) | -27.2 percent change | Standard Deviation 21.82 |
Secondary
Response to Subject Global Questions
Participants answered 3 questions on a 7-point scale that ranged from a great deal worse to a great deal better (questions 1 and 2) or from extremely dissatisfied to extremely satisfied (question 3). Question 1: Since the start of the study, how would you rate the fat under your chin right now? Question 2: Since the start of the study, how would you rate the definition between your chin and neck right now? Question 3: How satisfied are you with the treatment you received in this study?
Time frame: Month 3 and month 12 after last treatment
Population: Treatment effect population with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 3 - extremely dissatisfied | 1 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 1 - a great deal worse | 0 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 1 - moderately worse | 1 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 1 - a little worse | 0 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 1 - about the same | 6 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 1 - a little better | 22 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 1 - moderately better | 48 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 1 - a great deal better | 68 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 2 - a great deal worse | 0 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 2 - moderately worse | 0 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 2 - a little worse | 0 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 2 - about the same | 5 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 2 - a little better | 27 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 2 - moderately better | 53 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 2 - a great deal better | 60 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 3 - moderately dissatisfied | 0 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 3 - a little dissatisfied | 2 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 3 - neither dissatisfied nor satisfied | 5 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 3 - a little satisfied | 15 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 3 - moderately satisfied | 43 participants |
| Deoxycholic Acid 2 mg/cm² | Response to Subject Global Questions | Question 3 - extremely satisfied | 79 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 2 - a little worse | 0 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 2 - a great deal better | 59 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 3 - a little satisfied | 11 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 1 - a great deal worse | 0 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 2 - about the same | 5 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 1 - moderately worse | 1 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 3 - a little dissatisfied | 2 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 1 - a little worse | 1 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 2 - a little better | 27 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 1 - about the same | 7 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 3 - extremely satisfied | 79 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 1 - a little better | 23 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 2 - moderately better | 38 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 1 - moderately better | 32 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 3 - neither dissatisfied nor satisfied | 6 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 1 - a great deal better | 66 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 3 - extremely dissatisfied | 1 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 2 - a great deal worse | 0 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 3 - moderately satisfied | 30 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 2 - moderately worse | 1 participants |
| Month 12 After Last Treatment | Response to Subject Global Questions | Question 3 - moderately dissatisfied | 1 participants |