Moderate or Severe Submental Fullness
Conditions
Brief summary
Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).
Interventions
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
DRUGPlacebo
Sponsors
Kythera Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (SMF) rating scale * Good general health * Signed informed consent
Exclusion criteria
* History of any treatment in the neck or chin area * Loose skin or prominent platysmal bands in the neck or chin area * Recent treatment with anticoagulants * Presence of clinically significant health problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment). | The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale: * Mild: The participant is aware of a sign or symptom, but it is easily tolerated * Moderate: Discomfort or interference with usual activity * Severe: Incapacitating, with inability to engage in usual activity. A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that: * was fatal * was life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect * other significant medical hazard |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment). | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Response in the Subject Global Improvement Rating | 4 weeks after last treatment (up to 16 weeks after first dose) | Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause. 0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved. Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6. |
| Percentage of Participants With an SMF Response | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) | Response is defined as a participant with at least a 1-grade improvement in SMF Rating Scale score at Week 16 from Baseline. The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. |
| Change From Baseline in Skin Laxity Rating | Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment) | Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement. |
| Change From Baseline in Submental Fat (SMF) Rating Scale Score | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) | The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement. |
| Change From Baseline in the Cervicomental Angle | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) | The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement. |
| Visual Analogue Scale Pain Intensity Rating | Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12 | Participants rated pain associated with the submental area on a 100 mm horizontal axis ranging from 0 (no pain) to 100 (most severe pain possible) |
| Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment) | The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement. |
| Change From Baseline in Subject Satisfaction With Appearance Rating Scale | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) | The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 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
Australia, Canada, United Kingdom
Participant flow
Recruitment details
This study was conducted at 7 study centers: 4 in Canada, 2 in Australia and 1 in the United Kingdom.
Pre-assignment details
Participants were randomized to receive either deoxycholic acid or placebo injection in one of 3 treatment dosing regimens for a total of 6 treatment groups. Placebo participants were pooled for analysis.
Participants by arm
| Arm | Count |
|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. | 24 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. | 13 |
| Deoxycholic Acid Injection 0.4 mL/1.0 cm Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. | 20 |
| Pooled Placebo Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. | 14 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 |
| Overall Study | Did Not Meet Entry Criteria | 0 | 0 | 1 | 0 |
| Overall Study | Inability to Complete Study Procedures | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 0 | 0 | 1 |
| Overall Study | Non-compliance | 1 | 1 | 0 | 0 |
| Overall Study | Patient Request | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Deoxycholic Acid Injection 0.2 mL/0.7 cm | Deoxycholic Acid Injection 0.2 mL/1.0 cm | Deoxycholic Acid Injection 0.4 mL/1.0 cm | Pooled Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 47.1 years STANDARD_DEVIATION 8.69 | 46.5 years STANDARD_DEVIATION 7.79 | 45.9 years STANDARD_DEVIATION 4.23 | 47.0 years STANDARD_DEVIATION 10.37 | 49.4 years STANDARD_DEVIATION 10.85 |
| Fitzpatrick Skin Type I - III | 71 participants | 24 participants | 13 participants | 20 participants | 14 participants |
| Fitzpatrick Skin Type IV - VI | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 71 participants | 24 participants | 13 participants | 20 participants | 14 participants |
| Sex: Female, Male Female | 55 Participants | 19 Participants | 11 Participants | 15 Participants | 10 Participants |
| Sex: Female, Male Male | 16 Participants | 5 Participants | 2 Participants | 5 Participants | 4 Participants |
| Submental Fat (SMF) Rating 2 | 45 participants | 17 participants | 10 participants | 11 participants | 7 participants |
| Submental Fat (SMF) Rating 3 | 26 participants | 7 participants | 3 participants | 9 participants | 7 participants |
| Weight | 83.78 kg STANDARD_DEVIATION 16.074 | 78.31 kg STANDARD_DEVIATION 11.987 | 82.10 kg STANDARD_DEVIATION 18.204 | 90.80 kg STANDARD_DEVIATION 17.128 | 84.78 kg STANDARD_DEVIATION 16.381 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 24 / 24 | 13 / 13 | 20 / 20 | 14 / 14 |
| serious Total, serious adverse events | 0 / 24 | 1 / 13 | 0 / 20 | 0 / 14 |
Outcome results
Primary
Number of Participants With Adverse Events
The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale: * Mild: The participant is aware of a sign or symptom, but it is easily tolerated * Moderate: Discomfort or interference with usual activity * Severe: Incapacitating, with inability to engage in usual activity. A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that: * was fatal * was life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect * other significant medical hazard
Time frame: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Population: Safety/miTT subset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Number of Participants With Adverse Events | Any adverse event | 24 participants |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Number of Participants With Adverse Events | Discontinued due to adverse event | 2 participants |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Number of Participants With Adverse Events | Serious adverse event | 0 participants |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Number of Participants With Adverse Events | Adverse event associated with treatment area | 24 participants |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Number of Participants With Adverse Events | Deaths | 0 participants |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Number of Participants With Adverse Events | Study drug-related adverse event | 24 participants |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Number of Participants With Adverse Events | Study drug-related severe adverse event | 6 participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Number of Participants With Adverse Events | Discontinued due to adverse event | 1 participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Number of Participants With Adverse Events | Study drug-related severe adverse event | 0 participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Number of Participants With Adverse Events | Study drug-related adverse event | 13 participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Number of Participants With Adverse Events | Serious adverse event | 1 participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Number of Participants With Adverse Events | Deaths | 1 participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Number of Participants With Adverse Events | Adverse event associated with treatment area | 13 participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Number of Participants With Adverse Events | Any adverse event | 13 participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Number of Participants With Adverse Events | Study drug-related severe adverse event | 5 participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Number of Participants With Adverse Events | Any adverse event | 20 participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Number of Participants With Adverse Events | Adverse event associated with treatment area | 20 participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Number of Participants With Adverse Events | Study drug-related adverse event | 20 participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Number of Participants With Adverse Events | Serious adverse event | 0 participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Number of Participants With Adverse Events | Discontinued due to adverse event | 0 participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Number of Participants With Adverse Events | Deaths | 0 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Study drug-related adverse event | 14 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Deaths | 0 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Discontinued due to adverse event | 0 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Adverse event associated with treatment area | 14 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Any adverse event | 14 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Serious adverse event | 0 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Study drug-related severe adverse event | 0 participants |
Primary
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Time frame: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Population: Safety/mITT subset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Laboratory Values | 3 participants |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Weight | 0 participants |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Vital Signs | 0 participants |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Physical Examinations | 0 participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Weight | 0 participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Vital Signs | 0 participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Physical Examinations | 0 participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Laboratory Values | 0 participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Vital Signs | 1 participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Weight | 0 participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Physical Examinations | 0 participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Laboratory Values | 2 participants |
| Pooled Placebo | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Physical Examinations | 0 participants |
| Pooled Placebo | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Weight | 0 participants |
| Pooled Placebo | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Laboratory Values | 0 participants |
| Pooled Placebo | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Vital Signs | 0 participants |
Secondary
Change From Baseline in Skin Laxity Rating
Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement.
Time frame: Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Population: Safety/mITT subset
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline in Skin Laxity Rating | Week 12 | -0.1 units on a scale | Standard Deviation 0.51 |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline in Skin Laxity Rating | Week 4 | -0.1 units on a scale | Standard Deviation 0.34 |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline in Skin Laxity Rating | Week 16 | -0.2 units on a scale | Standard Deviation 0.6 |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline in Skin Laxity Rating | Week 8 | -0.2 units on a scale | Standard Deviation 0.59 |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline in Skin Laxity Rating | Week 24 | -0.2 units on a scale | Standard Deviation 0.68 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline in Skin Laxity Rating | Week 12 | -0.2 units on a scale | Standard Deviation 0.39 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline in Skin Laxity Rating | Week 8 | 0.1 units on a scale | Standard Deviation 0.3 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline in Skin Laxity Rating | Week 16 | -0.3 units on a scale | Standard Deviation 0.48 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline in Skin Laxity Rating | Week 4 | -0.1 units on a scale | Standard Deviation 0.64 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline in Skin Laxity Rating | Week 24 | -0.4 units on a scale | Standard Deviation 0.67 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline in Skin Laxity Rating | Week 24 | -0.1 units on a scale | Standard Deviation 0.66 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline in Skin Laxity Rating | Week 4 | -0.2 units on a scale | Standard Deviation 0.54 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline in Skin Laxity Rating | Week 8 | -0.1 units on a scale | Standard Deviation 0.57 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline in Skin Laxity Rating | Week 12 | -0.2 units on a scale | Standard Deviation 0.71 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline in Skin Laxity Rating | Week 16 | -0.2 units on a scale | Standard Deviation 0.59 |
| Pooled Placebo | Change From Baseline in Skin Laxity Rating | Week 24 | -0.2 units on a scale | Standard Deviation 0.55 |
| Pooled Placebo | Change From Baseline in Skin Laxity Rating | Week 16 | -0.1 units on a scale | Standard Deviation 0.53 |
| Pooled Placebo | Change From Baseline in Skin Laxity Rating | Week 8 | -0.1 units on a scale | Standard Deviation 0.66 |
| Pooled Placebo | Change From Baseline in Skin Laxity Rating | Week 4 | 0.0 units on a scale | Standard Deviation 0.78 |
| Pooled Placebo | Change From Baseline in Skin Laxity Rating | Week 12 | -0.1 units on a scale | Standard Deviation 0.53 |
Comparison: Week 4p-value: 0.4695% CI: [-0.5, 0.2]Repeated Measures
Comparison: Week 4p-value: 0.90695% CI: [-0.5, 0.4]Repeated Measures
Comparison: Week 4p-value: 0.40495% CI: [-0.6, 0.2]Repeated Measures
Comparison: Week 8p-value: 0.79195% CI: [-0.5, 0.3]Repeated Measures
Comparison: Week 8p-value: 0.4195% CI: [-0.3, 0.6]Repeated Measures
Comparison: Week 8p-value: 0.73395% CI: [-0.3, 0.5]Repeated Measures
Comparison: Week 12p-value: 0.54295% CI: [-0.3, 0.5]Repeated Measures
Comparison: Week 12p-value: 0.88295% CI: [-0.4, 0.5]Repeated Measures
Comparison: Week 12p-value: 0.93495% CI: [-0.4, 0.4]Repeated Measures
Comparison: Week 16p-value: 0.83895% CI: [-0.4, 0.4]Repeated Measures
Comparison: Week 16p-value: 0.77795% CI: [-0.5, 0.4]Repeated Measures
Comparison: Week 16p-value: 0.79595% CI: [-0.4, 0.5]Repeated Measures
Comparison: Week 24p-value: 0.85295% CI: [-0.4, 0.4]Repeated Measures
Comparison: Week 24p-value: 0.44495% CI: [-0.6, 0.3]Repeated Measures
Comparison: Week 24p-value: 0.72495% CI: [-0.3, 0.5]Repeated Measures
Secondary
Change From Baseline in Subject Satisfaction With Appearance Rating Scale
The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 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 4 weeks after last treatment (up to 16 weeks after first dose)
Population: Safety/mITT subset with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline in Subject Satisfaction With Appearance Rating Scale | 3.5 units on a scale | Standard Deviation 1.47 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline in Subject Satisfaction With Appearance Rating Scale | 4.3 units on a scale | Standard Deviation 1.34 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline in Subject Satisfaction With Appearance Rating Scale | 2.8 units on a scale | Standard Deviation 2.2 |
| Pooled Placebo | Change From Baseline in Subject Satisfaction With Appearance Rating Scale | 1.8 units on a scale | Standard Deviation 1.72 |
p-value: 0.00595% CI: [0.6, 3]ANCOVA
p-value: 0.00195% CI: [1, 4]ANCOVA
p-value: 0.12295% CI: [-0.3, 2.2]ANCOVA
Secondary
Change From Baseline in Submental Fat (SMF) Rating Scale Score
The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.
Time frame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Population: Safety/mITT subset with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline in Submental Fat (SMF) Rating Scale Score | -1.0 units on a scale | Standard Deviation 0.58 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline in Submental Fat (SMF) Rating Scale Score | -1.2 units on a scale | Standard Deviation 0.63 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline in Submental Fat (SMF) Rating Scale Score | -0.8 units on a scale | Standard Deviation 0.72 |
| Pooled Placebo | Change From Baseline in Submental Fat (SMF) Rating Scale Score | -0.4 units on a scale | Standard Deviation 0.5 |
p-value: 0.00595% CI: [-1, -0.2]ANCOVA
p-value: 0.00195% CI: [-1.4, -0.4]ANCOVA
p-value: 0.06995% CI: [-0.8, 0]ANCOVA
Secondary
Change From Baseline in the Cervicomental Angle
The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.
Time frame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Population: Safety/mITT subset with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline in the Cervicomental Angle | -5.0 degrees | Standard Deviation 9.85 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline in the Cervicomental Angle | -1.5 degrees | Standard Deviation 7.84 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline in the Cervicomental Angle | -1.5 degrees | Standard Deviation 10.4 |
| Pooled Placebo | Change From Baseline in the Cervicomental Angle | -2.7 degrees | Standard Deviation 7.8 |
p-value: 0.57395% CI: [-8.6, 4.8]ANCOVA
p-value: 0.65395% CI: [-6.3, 9.9]ANCOVA
p-value: 0.68895% CI: [-5.4, 8.1]ANCOVA
Secondary
Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score
The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.
Time frame: Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Population: Safety/mITT subset
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 16 | -1.0 units on a scale | Standard Deviation 0.58 |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 8 | -0.6 units on a scale | Standard Deviation 0.67 |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 24 | -1.0 units on a scale | Standard Deviation 0.45 |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 12 | -0.9 units on a scale | Standard Deviation 0.59 |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 4 | -0.3 units on a scale | Standard Deviation 0.57 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 12 | -1.0 units on a scale | Standard Deviation 0.74 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 16 | -1.2 units on a scale | Standard Deviation 0.63 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 24 | -1.2 units on a scale | Standard Deviation 0.87 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 8 | -0.6 units on a scale | Standard Deviation 0.67 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 4 | -0.5 units on a scale | Standard Deviation 0.52 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 12 | -0.7 units on a scale | Standard Deviation 0.59 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 4 | -0.1 units on a scale | Standard Deviation 0.32 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 8 | -0.5 units on a scale | Standard Deviation 0.61 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 16 | -0.8 units on a scale | Standard Deviation 0.72 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 24 | -1.0 units on a scale | Standard Deviation 0.67 |
| Pooled Placebo | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 16 | -0.4 units on a scale | Standard Deviation 0.5 |
| Pooled Placebo | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 8 | -0.4 units on a scale | Standard Deviation 0.5 |
| Pooled Placebo | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 4 | -0.3 units on a scale | Standard Deviation 0.47 |
| Pooled Placebo | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 12 | -0.4 units on a scale | Standard Deviation 0.51 |
| Pooled Placebo | Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score | Week 24 | -0.4 units on a scale | Standard Deviation 0.51 |
Comparison: Week 4p-value: 0.93495% CI: [-0.4, 0.4]Repeated Measures
Comparison: Week 4p-value: 0.28695% CI: [-0.7, 0.2]Repeated Measures
Comparison: Week 4p-value: 0.1995% CI: [-0.1, 0.7]Repeated Measures
Comparison: Week 8p-value: 0.40295% CI: [-0.5, 0.2]Repeated Measures
Comparison: Week 8p-value: 0.2995% CI: [-0.7, 0.2]Repeated Measures
Comparison: Week 8p-value: 0.86395% CI: [-0.4, 0.4]Repeated Measures
Comparison: Week 12p-value: 0.12895% CI: [-0.7, 0.1]Repeated Measures
Comparison: Week 12p-value: 0.01895% CI: [-0.9, -0.1]Repeated Measures
Comparison: Week 12p-value: 0.48995% CI: [-0.5, 0.3]Repeated Measures
Comparison: Week 16p-value: 0.00795% CI: [-0.9, -0.1]Repeated Measures
Comparison: Week 16p-value: <0.00195% CI: [-1.3, -0.4]Repeated Measures
Comparison: Week 16p-value: 0.12295% CI: [-0.7, 0.1]Repeated Measures
Comparison: Week 24p-value: 0.00595% CI: [-0.9, -0.2]Repeated Measures
Comparison: Week 24p-value: <0.00195% CI: [-1.2, -0.3]Repeated Measures
Comparison: Week 24p-value: 0.00795% CI: [-1, -0.2]Repeated Measures
Secondary
Percentage of Participants With an SMF Response
Response is defined as a participant with at least a 1-grade improvement in SMF Rating Scale score at Week 16 from Baseline. The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Time frame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Population: Safety/mITT subset with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Percentage of Participants With an SMF Response | 81.8 percentage of participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Percentage of Participants With an SMF Response | 90.0 percentage of participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Percentage of Participants With an SMF Response | 60.0 percentage of participants |
| Pooled Placebo | Percentage of Participants With an SMF Response | 35.7 percentage of participants |
p-value: 0.01195% CI: [16.3, 75.9]Fisher Exact
p-value: 0.01395% CI: [23, 85.5]Fisher Exact
p-value: 0.29695% CI: [-8.7, 57.3]Fisher Exact
Secondary
Percentage of Participants With a Response in the Subject Global Improvement Rating
Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause. 0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved. Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6.
Time frame: 4 weeks after last treatment (up to 16 weeks after first dose)
Population: Safety/mITT subset with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Percentage of Participants With a Response in the Subject Global Improvement Rating | 95.5 percentage of participants |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Percentage of Participants With a Response in the Subject Global Improvement Rating | 90.0 percentage of participants |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Percentage of Participants With a Response in the Subject Global Improvement Rating | 80.0 percentage of participants |
| Pooled Placebo | Percentage of Participants With a Response in the Subject Global Improvement Rating | 57.1 percentage of participants |
p-value: 0.00895% CI: [11, 65.7]Fisher Exact
p-value: 0.17295% CI: [1, 64.8]Fisher Exact
p-value: 0.25295% CI: [-8.4, 54.2]Fisher Exact
Secondary
Visual Analogue Scale Pain Intensity Rating
Participants rated pain associated with the submental area on a 100 mm horizontal axis ranging from 0 (no pain) to 100 (most severe pain possible)
Time frame: Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12
Population: Safety/mITT subset with available data at each time point (indicated by N)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Visual Analogue Scale Pain Intensity Rating | Treatment 2 (N=19, 10, 16, 14) | 27.9 units on a scale | Standard Deviation 27.69 |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Visual Analogue Scale Pain Intensity Rating | Treatment 4 (N=14, 10, 15, 14) | 14.0 units on a scale | Standard Deviation 18.68 |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Visual Analogue Scale Pain Intensity Rating | Treatment 1 (N=24, 12, 20, 14) | 33.0 units on a scale | Standard Deviation 27.29 |
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Visual Analogue Scale Pain Intensity Rating | Treatment 3 (N=17, 10, 16, 13) | 26.5 units on a scale | Standard Deviation 28.5 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Visual Analogue Scale Pain Intensity Rating | Treatment 1 (N=24, 12, 20, 14) | 25.8 units on a scale | Standard Deviation 16.19 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Visual Analogue Scale Pain Intensity Rating | Treatment 4 (N=14, 10, 15, 14) | 13.7 units on a scale | Standard Deviation 14.55 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Visual Analogue Scale Pain Intensity Rating | Treatment 2 (N=19, 10, 16, 14) | 38.2 units on a scale | Standard Deviation 26.62 |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Visual Analogue Scale Pain Intensity Rating | Treatment 3 (N=17, 10, 16, 13) | 19.2 units on a scale | Standard Deviation 25.35 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Visual Analogue Scale Pain Intensity Rating | Treatment 1 (N=24, 12, 20, 14) | 41.9 units on a scale | Standard Deviation 27.5 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Visual Analogue Scale Pain Intensity Rating | Treatment 4 (N=14, 10, 15, 14) | 19.0 units on a scale | Standard Deviation 24.74 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Visual Analogue Scale Pain Intensity Rating | Treatment 3 (N=17, 10, 16, 13) | 22.6 units on a scale | Standard Deviation 30.77 |
| 0Deoxycholic Acid Injection 0.4 mL/1.0 cm | Visual Analogue Scale Pain Intensity Rating | Treatment 2 (N=19, 10, 16, 14) | 31.1 units on a scale | Standard Deviation 31 |
| Pooled Placebo | Visual Analogue Scale Pain Intensity Rating | Treatment 4 (N=14, 10, 15, 14) | 16.7 units on a scale | Standard Deviation 27.27 |
| Pooled Placebo | Visual Analogue Scale Pain Intensity Rating | Treatment 2 (N=19, 10, 16, 14) | 24.9 units on a scale | Standard Deviation 28.73 |
| Pooled Placebo | Visual Analogue Scale Pain Intensity Rating | Treatment 3 (N=17, 10, 16, 13) | 20.7 units on a scale | Standard Deviation 27.21 |
| Pooled Placebo | Visual Analogue Scale Pain Intensity Rating | Treatment 1 (N=24, 12, 20, 14) | 17.1 units on a scale | Standard Deviation 19.03 |